Covid 19 Research using Clinical Trials (Home Page)
HP:0001824: Weight lossHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1700 | Med-South Weight Loss Intervention Wiki | 0.58 |
| drug1788 | Multi Modal Balance Training Wiki | 0.58 |
| drug2072 | Patient-only intervention Wiki | 0.58 |
| drug2060 | Partner-assisted intervention Wiki | 0.58 |
| drug3119 | Weight Loss Wiki | 0.58 |
| drug3104 | WW Wiki | 0.58 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VAMHCS. Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
NCT02806336 Obesity Dysmobility Behavioral: Multi Modal Balance Training Behavioral: Weight Loss MeSH:Weight Loss
HPO:Decreased body weight Weight loss
Primary Outcomes
Description: Distance walked during the 6 minute walking test
Measure: Change in 6 minute walk distance Time: baseline, 3 months, 6 months, 12 months, 24 months
Secondary Outcomes
Description: VO2peak measured during graded exercise treadmill test to volitional fatigue
Measure: Change in VO2peak Time: baseline, 6 months, 12 months, 24 months
Description: 6 minute walk with submaximal assessment of oxygen uptake.
Measure: Change in 6 minute walk with VO2 measurement Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: DXA scan
Measure: Change in Muscle mass/body composition as assessed by DXA scan Time: baseline, 6 months, 12 months, 24 months
Description: LLDFI Questionnaires
Measure: Change in Quality of Life, LLDFI Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Gait biomechanics as assessed by walking mechanics on the GAITmat
Measure: Change in gait biomechanics Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Component scores of the standing balance battery, usual gait speed, and repeated chair stands (which make up the short physical performance battery test); as well as overall short physical performance battery score
Measure: Change in short physical performance battery Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Dynamic test of balance involving change in stepping direction.
Measure: Change in four square step test Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Measure: Change in 8 foot up and go Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: CT scan
Measure: Change in Muscle mass/body composition as assessed by CT scan Time: baseline, 6 months, 12 months, 24 months
Description: Self-reported ability to complete activities of daily living and independent activities of daily living.
Measure: Change in ADL/IADL questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Self-reported physical activities questionnaire.
Measure: Change in CHAMPS questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 months
Description: Questionnaire assessing global cognitive function
Measure: Change in MoCA Time: baseline, 3 months, 6 months, 12 months, 24 months
2 Using Partners to Enhance Long-Term Weight Loss
Primary Outcomes
Description: Distance walked during the 6 minute walking test
Measure: Change in 6 minute walk distance Time: baseline, 3 months, 6 months, 12 months, 24 monthsSecondary Outcomes
Description: VO2peak measured during graded exercise treadmill test to volitional fatigue
Measure: Change in VO2peak Time: baseline, 6 months, 12 months, 24 monthsDescription: 6 minute walk with submaximal assessment of oxygen uptake.
Measure: Change in 6 minute walk with VO2 measurement Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: DXA scan
Measure: Change in Muscle mass/body composition as assessed by DXA scan Time: baseline, 6 months, 12 months, 24 monthsDescription: LLDFI Questionnaires
Measure: Change in Quality of Life, LLDFI Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Gait biomechanics as assessed by walking mechanics on the GAITmat
Measure: Change in gait biomechanics Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Component scores of the standing balance battery, usual gait speed, and repeated chair stands (which make up the short physical performance battery test); as well as overall short physical performance battery score
Measure: Change in short physical performance battery Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Dynamic test of balance involving change in stepping direction.
Measure: Change in four square step test Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Measure: Change in 8 foot up and go Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: CT scan
Measure: Change in Muscle mass/body composition as assessed by CT scan Time: baseline, 6 months, 12 months, 24 monthsDescription: Self-reported ability to complete activities of daily living and independent activities of daily living.
Measure: Change in ADL/IADL questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Self-reported physical activities questionnaire.
Measure: Change in CHAMPS questionnaire Time: baseline, 3 months, 6 months, 12 months, 24 monthsDescription: Questionnaire assessing global cognitive function
Measure: Change in MoCA Time: baseline, 3 months, 6 months, 12 months, 24 monthsThis study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
NCT03801174 Obesity Behavioral: Partner-assisted intervention Behavioral: Patient-only intervention MeSH:Weight Loss
HPO:Decreased body weight Weight loss
Primary Outcomes
Description: Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
Measure: Body weight (kg) Time: 24 months
Secondary Outcomes
Description: average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Measure: Caloric intake (kcal) Time: 24 months
Description: average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Measure: Physical activity Time: 24 months
Other Outcomes
Description: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for diet Time: 3 months
Description: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for diet Time: 3 months
Description: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for diet Time: 3 months
Description: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for diet Time: 3 months
Description: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for diet Time: 3 months
Description: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for physical activity Time: 3 months
Description: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for physical activity Time: 3 months
Description: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for physical activity Time: 3 months
Description: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for physical activity Time: 3 months
Description: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for physical activity Time: 3 months
3 Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices
Primary Outcomes
Description: Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
Measure: Body weight (kg) Time: 24 monthsSecondary Outcomes
Description: average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint
Measure: Caloric intake (kcal) Time: 24 monthsDescription: average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint
Measure: Physical activity Time: 24 monthsOther Outcomes
Description: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for diet Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for diet Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for diet Time: 3 monthsDescription: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for diet Time: 3 monthsDescription: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for diet Time: 3 monthsDescription: Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)
Measure: Transformation of motivation for physical activity Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)
Measure: Outcome efficacy for physical activity Time: 3 monthsDescription: 5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)
Measure: Couple efficacy for physical activity Time: 3 monthsDescription: 9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)
Measure: Social support for physical activity Time: 3 monthsDescription: 5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)
Measure: Use of communal coping strategies for physical activity Time: 3 monthsThis study will compare a new weight loss program that focuses on a healthy eating pattern, with WW™ (formally Weight Watchers), an effective and widely available weight loss program. Study researchers have developed an adapted version of the Mediterranean eating pattern to be more acceptable and realistic for southerners; this adapted version is known as "Med-South." Those who take part in the study will be randomly assigned to either the Med-South weight loss program or WW™. Both programs will last for 2 years with measurement visits at the start of the study and at 4-, 12- and 24-month follow-up. While the primary outcome measured by the trial will be weight loss at 24 months, researchers will collect other data which may show additional health benefits of the Med-South diet. The study team will measure blood markers of inflammation, which are known to improve with better diet quality. Researchers will also measure participants' skin carotenoid levels, which increase with greater fruit and vegetable consumption. The study will be conducted within 2 regional catchment areas (n=360 participants) representing a diverse spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m^2 will be enrolled and randomized to intervention or augmented usual care. To assure adequate subgroup representation, ≥ 40% of the sample will have diabetes, ≥ 40% will be male, and ≥ 40% will be African American. The intervention will be delivered in 3 phases over 24 months by research staff: Phase I (4 months) focuses on adopting a Med-style dietary pattern; Phase II (8 months) on weight loss; and Phase III (12 months) on weight loss maintenance. Outcomes will be assessed at 4, 12, and 24 months. The primary outcome is weight loss at 24 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures. Researchers will also assess implementation cost and the incremental cost-effectiveness of the intervention relative to the augmented usual care group.
NCT04302727 Weight Loss Diet, Healthy Cardiovascular Risk Factor Behavioral: Med-South Weight Loss Intervention Behavioral: WW MeSH:Weight Loss
HPO:Decreased body weight Weight loss
Primary Outcomes
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Month 24 Time: Baseline, Month 24
Secondary Outcomes
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Months 4 and 12 Time: Baseline, Months 4 and 12
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Change in weight will be assessed across 3 pre-specified subgroups: 1) with vs. without diabetes; 2) females vs. males; and 3) whites vs. African Americans.
Measure: Mean Weight Change from Baseline through Follow-Up by Sub-Groups Time: Baseline, Months 4, 12, and 24
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Assess difference between study groups in percentage losing ≥ 5% body weight for all participants and across 3 pre-specified subgroups: 1) participants with vs. without diabetes; 2) females vs. males; and 3) Whites vs. African Americans.
Measure: Percentage Weight from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24
Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Systolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24
Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24
Description: Total cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in Total Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: HDL-Cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in HDL-Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Triglycerides as assessed by commercial lab (LabCorp).
Measure: Mean Change in Triglycerides from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Calculated from above lipid assessments by commercial lab (LabCorp).
Measure: Mean Change LDL-cholesterol from Baseline through Follow-up Time: Baseline, Month 4, 12, and 24
Description: A1c assessed by commercial lab (LabCorp).
Measure: Mean Change in A1c from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: CRP assessed by commercial lab (LabCorp).
Measure: Mean Change in CRP from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in IL-6 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in TNF-alpha from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation.
Measure: Mean Change in Skin Carotenoids from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: The Euro Quality of Life five Dimensions Questionnaire EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Mean Change in Quality of Life Scale from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: The AHEI-2010 is calculated from items on the Willett Food Frequency Questionnaire. It addresses intake of foods and nutrients consistently associated with lower risk for chronic diseases in the literature. The AHEI-2010 score is comprised of 11 sub-scales, each scored from 0 to 10, yielding a total score with a range of 0-110. A higher score indicates a more healthful dietary pattern.
Measure: Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: The GPAQ was developed by the WHO for physical activity surveillance. It collects information on physical activity participation in three settings (or domains) as well as sedentary behavior. The domains are: activity at work, travel to and from places, and recreational activities. The summary measure will be the sum of all activity per day with a higher score indication more physical activity.
Measure: Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: The Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF1) is a short version of the original Weight-Efficacy Lifestyle Questionnaire and includes 8 questions and 1 situational component representing "confidence in ability to resist eating." Three of the questions are related to emotional eating situations, two to availability, one to social pressure, one to positive activities, and one to physical discomfort.
Scoring: The instrument range scores on a Likert-scale from 0 (not at all confident) to 10 (very confident), with sum scores between 0 and 80. High scores are associated with high eating self-efficacy.
Measure: Mean Change in Weight Loss Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Treatment Self-regulation Questionnaire (TSRQ) measures the quality of motivation for a particular health goal. Motivation is psychological energy directed at a particular goal such as weight loss. This measure assesses three types of motivation: autonomous self-regulation, controlled self-regulation, and a-motivation or lack of motivation. This 15-item scale will focus on the reasons why people would either start eating a healthier diet or continue to do so.
Scoring: Participants rate each statement on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true). It assesses the degree to which a person's motivation for eating a healthy diet is autonomous or self-determined. The three sub-scale scores can be used separately or a Relative Autonomous Motivation score can be calculated. A higher score indicates greater motivation.
Measure: Mean Change in Dietary Self-Regulation from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: The Three Factor Eating Questionnaire (18 item revised version) measures eating attitudes with scales representing three dimensions of eating behavior: cognitive restraint (control over food intake in order to influence body weight / body shape), uncontrolled eating (loss of control over eating), and emotional eating (eating in response to positive and negative emotions).
Scoring: Each scale (dimension) is scored separately. Six of the eighteen items measure cognitive restraint, nine measure uncontrolled eating, and three measure emotional eating. Higher scores indicate greater cognitive restraint.
Measure: Mean Change in Eating Attitudes from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Perceived self-efficacy is regarded as a suitable predictor of behavioral intentions and reported health behaviors. This 5-item scale of perceived self-efficacy measuring action self-efficacy and coping self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.'
Scoring: Higher scores indicate higher perceived self-efficacy.
Validation: Evidence for the validity of the scales has been published in several articles. Cronbach's alpha for the nutrition self-efficacy measure ranges from 0.79 to 0.85.
Measure: Mean Change in Diet Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: EARLY Self-Weighing Questionnaire: This is a 2-item screener measures frequency of self-weighing and access to a bathroom scale. It was adapted from the Pound of Prevention Health Habits Questionnaire, Year 2. Validity of construct confirmed in Linde et al, 2005, as reports of higher weighing frequency was associated with greater 24-month weight loss or less weight gain.
Scoring: Higher scores indicate higher frequency of self-weighing and access to a bathroom scale.
Measure: Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24
Description: Computed as the incremental cost per kilogram of weight loss relative to control.
The budgetary assessment will quantify the total and per participant costs of intervention delivery from the health system perspective using an Activity Based Costing (ABC) approach and cost tracking forms that the health economist (Finkelstein) has developed and refined in past behavioral trials. Using this approach, all relevant labor, materials and supplies, contracted services, and other relevant costs required to deliver the interventions will be captured by key activities
Measure: Economic Outcome--Incremental Cost-Effectiveness Time: Month 24
Description: The numerator for this analysis will be the incremental program delivery costs of the intervention relative to control, minus any cost offsets based on differences in health services and medication use across arms. The denominator will be the incremental QALYs based on average differences in Euro Quality of Life five Dimensions Questionnaire (EQ-5D-5L) scores across arms collected at each assessment point. These scores can be used to quantify net QALY differences during the intervention period.
EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). The score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained Time: Month 24
HPO Nodes
HP:0001824: Weight loss
Genes 324
FANCE NALCN CBL DNAJC13 HTT TTR PDX1 COL6A2 BIRC3 ABCC8 NAB2 JAK2 SDHB CEP152 SDHAF2 GBA FANCL VHL PTEN STAT5B RFWD3 PMS2 POLG EPCAM POLG NF1 TP53 SDHB SCNN1A MEFV TP53 IL12A-AS1 SLC11A1 CTLA4 KCNJ11 ATRX MLX BRIP1 GPR35 PTEN THPO STAT3 PML TYMP IGH RRM2B HLCS HSPG2 CCR1 MALT1 SDHD GPC3 MLH3 RRM2B MSH2 CCND1 KLRC4 KCNJ18 SDHC SDHC FH JPH3 FANCF TSHR GIGYF2 POLG PALLD HLA-B TCF4 CDKN2A RUNX1 EDN3 BCOR SDHB BRCA2 ERCC3 NOD2 HLA-DRB1 KRT1 PRNP GJA1 BCL10 IRF2BP2 MRAP BCL6 SUCLA2 RHBDF2 FANCG B2M BCL2 ZBTB16 SNCA SLX4 PALB2 KIF1B HLA-DQA1 SCNN1A TGFBR2 KCNJ11 KRAS SDHD SDHA SMAD4 HLA-B INS FANCI POU6F2 UNC80 DAXX C4A IKZF1 CNTNAP1 ATM LIPA UBAC2 FANCD2 NUMA1 COL6A1 LRP12 FANCA RARA RB1 MST1 SLC39A4 EPAS1 PTPN22 SEMA4A KRT10 TRPV4 PCNT F5 SLC25A11 EWSR1 XRCC2 TRIM28 GALC NDP VPS35 MPL AK2 FIP1L1 ASXL1 CDC73 WT1 WT1 TXNRD2 SEMA3D HLA-DPB1 UBE2T TP53 HLA-DPA1 ERCC4 MPL TRIM28 TLR4 NPM1 SCNN1B ACAT1 PIK3CA GDNF SDHD FAN1 FANCB PLA2G6 FAS HLA-DQB1 CENPE RAD51 STAR ERCC5 CHEK2 SDHD IL12A IGH RET LPIN2 FANCM SLC6A8 ERCC4 SNCA SDHAF1 CRLF1 DLST REST PANK2 SLC9A6 SDHA PRKAR1A LRRK2 EDNRB BMPR1A FLI1 CACNA1S TET2 TET2 ABCC8 PTEN MC2R ATP7B ERCC4 UNC80 GNPTAB NABP1 ATRIP IL10 IFNGR1 IL12B GCK SCNN1G HLA-DRB1 STAT4 RNF168 ZFP57 COL6A3 IL23R BMPR1A COL12A1 DIS3L2 ERAP1 FOXP1 CACNA1S STAT3 STAT6 CALR VPS13A MPL MAFB CENPJ TSHR WT1 BRCA1 TRIP13 NNT TP53 RAD51C BRCA2 AKT1 COL5A1 BTNL2 TBL1XR1 GJB4 CCND1 PTPN22 MSH6 PMS1 ERCC2 PRNP GJB3 TYMP NOS1 JPH3 TMEM127 ACADM GATA2 SDHB BRCA1 CYP24A1 LMNA PRTN3 MLH1 MDH2 SRSF2 DNMT3A HLA-B IGH KRAS DCTN1 BRCA2 JAK2 HMGCL MAD2L2 RET FANCC COL1A1 PLK4 PRNP GATA4 ECE1 AVP FOXP3 TRIM37 PLAGL1 HMBS RBBP8 NOD2 DCTN1 KDSR SEMA3C PIK3R1 MAX SCNN1G KIF1B RPS20 JAK2 GALT COL5A2 RET NRTN H19 CFTR ATR TRAIP KCNJ18 HLA-DQB1 HLA-DRB1 PSAP CDH23 EIF2AK3 MECP2 BTK HLA-DRB1 HYMAI IL6 EIF4G1 CUL4B NBN TGFB1 PALB2 VHL SCNN1B HAVCR2 TET2 JAK2 GABRA3
Primary Outcomes
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Month 24 Time: Baseline, Month 24Secondary Outcomes
Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Measure: Mean Weight Change from Baseline to Months 4 and 12 Time: Baseline, Months 4 and 12Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Change in weight will be assessed across 3 pre-specified subgroups: 1) with vs. without diabetes; 2) females vs. males; and 3) whites vs. African Americans.
Measure: Mean Weight Change from Baseline through Follow-Up by Sub-Groups Time: Baseline, Months 4, 12, and 24Description: Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Assess difference between study groups in percentage losing ≥ 5% body weight for all participants and across 3 pre-specified subgroups: 1) participants with vs. without diabetes; 2) females vs. males; and 3) Whites vs. African Americans.
Measure: Percentage Weight from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Systolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Blood pressure assessed by Omron-907xl, average of 3 readings.
Measure: Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up Time: Baseline, Months 4, 12, and 24Description: Total cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in Total Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: HDL-Cholesterol assessed by commercial lab (LabCorp).
Measure: Mean Change in HDL-Cholesterol from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Triglycerides as assessed by commercial lab (LabCorp).
Measure: Mean Change in Triglycerides from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Calculated from above lipid assessments by commercial lab (LabCorp).
Measure: Mean Change LDL-cholesterol from Baseline through Follow-up Time: Baseline, Month 4, 12, and 24Description: A1c assessed by commercial lab (LabCorp).
Measure: Mean Change in A1c from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: CRP assessed by commercial lab (LabCorp).
Measure: Mean Change in CRP from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in IL-6 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Assessed by independent lab blinded to participant arm.
Measure: Mean Change in TNF-alpha from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation.
Measure: Mean Change in Skin Carotenoids from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Euro Quality of Life five Dimensions Questionnaire EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Mean Change in Quality of Life Scale from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The AHEI-2010 is calculated from items on the Willett Food Frequency Questionnaire. It addresses intake of foods and nutrients consistently associated with lower risk for chronic diseases in the literature. The AHEI-2010 score is comprised of 11 sub-scales, each scored from 0 to 10, yielding a total score with a range of 0-110. A higher score indicates a more healthful dietary pattern.
Measure: Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The GPAQ was developed by the WHO for physical activity surveillance. It collects information on physical activity participation in three settings (or domains) as well as sedentary behavior. The domains are: activity at work, travel to and from places, and recreational activities. The summary measure will be the sum of all activity per day with a higher score indication more physical activity.
Measure: Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF1) is a short version of the original Weight-Efficacy Lifestyle Questionnaire and includes 8 questions and 1 situational component representing "confidence in ability to resist eating." Three of the questions are related to emotional eating situations, two to availability, one to social pressure, one to positive activities, and one to physical discomfort. Scoring: The instrument range scores on a Likert-scale from 0 (not at all confident) to 10 (very confident), with sum scores between 0 and 80. High scores are associated with high eating self-efficacy.
Measure: Mean Change in Weight Loss Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Treatment Self-regulation Questionnaire (TSRQ) measures the quality of motivation for a particular health goal. Motivation is psychological energy directed at a particular goal such as weight loss. This measure assesses three types of motivation: autonomous self-regulation, controlled self-regulation, and a-motivation or lack of motivation. This 15-item scale will focus on the reasons why people would either start eating a healthier diet or continue to do so. Scoring: Participants rate each statement on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true). It assesses the degree to which a person's motivation for eating a healthy diet is autonomous or self-determined. The three sub-scale scores can be used separately or a Relative Autonomous Motivation score can be calculated. A higher score indicates greater motivation.
Measure: Mean Change in Dietary Self-Regulation from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: The Three Factor Eating Questionnaire (18 item revised version) measures eating attitudes with scales representing three dimensions of eating behavior: cognitive restraint (control over food intake in order to influence body weight / body shape), uncontrolled eating (loss of control over eating), and emotional eating (eating in response to positive and negative emotions). Scoring: Each scale (dimension) is scored separately. Six of the eighteen items measure cognitive restraint, nine measure uncontrolled eating, and three measure emotional eating. Higher scores indicate greater cognitive restraint.
Measure: Mean Change in Eating Attitudes from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Perceived self-efficacy is regarded as a suitable predictor of behavioral intentions and reported health behaviors. This 5-item scale of perceived self-efficacy measuring action self-efficacy and coping self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.' Scoring: Higher scores indicate higher perceived self-efficacy. Validation: Evidence for the validity of the scales has been published in several articles. Cronbach's alpha for the nutrition self-efficacy measure ranges from 0.79 to 0.85.
Measure: Mean Change in Diet Self-Efficacy from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: EARLY Self-Weighing Questionnaire: This is a 2-item screener measures frequency of self-weighing and access to a bathroom scale. It was adapted from the Pound of Prevention Health Habits Questionnaire, Year 2. Validity of construct confirmed in Linde et al, 2005, as reports of higher weighing frequency was associated with greater 24-month weight loss or less weight gain. Scoring: Higher scores indicate higher frequency of self-weighing and access to a bathroom scale.
Measure: Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up Time: Baseline, Month 4, 12, and 24Description: Computed as the incremental cost per kilogram of weight loss relative to control. The budgetary assessment will quantify the total and per participant costs of intervention delivery from the health system perspective using an Activity Based Costing (ABC) approach and cost tracking forms that the health economist (Finkelstein) has developed and refined in past behavioral trials. Using this approach, all relevant labor, materials and supplies, contracted services, and other relevant costs required to deliver the interventions will be captured by key activities
Measure: Economic Outcome--Incremental Cost-Effectiveness Time: Month 24Description: The numerator for this analysis will be the incremental program delivery costs of the intervention relative to control, minus any cost offsets based on differences in health services and medication use across arms. The denominator will be the incremental QALYs based on average differences in Euro Quality of Life five Dimensions Questionnaire (EQ-5D-5L) scores across arms collected at each assessment point. These scores can be used to quantify net QALY differences during the intervention period. EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). The score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Measure: Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained Time: Month 24