Obesity Clinical Trial
Official title:
Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss
Verified date | April 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
People with elevated blood pressure are at higher risk of having a heart attack or stroke than people with lower blood pressure. Losing a modest amount of weight-such as 15 or 20 pounds-can reduce the risk of having a heart attack or stroke. However, it can often be a struggle to maintain weight loss over time. This study examines whether two behavioral weight-management programs can help people maintain weight loss over time. In this study, 346 adults will be randomly assigned (like flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years) to see how their body weight may change.
Status | Completed |
Enrollment | 321 |
Est. completion date | January 27, 2022 |
Est. primary completion date | January 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria (BMI): - 27 <= BMI < 45 kg/m2 Inclusion Criteria (Elevated Blood Pressure): - Systolic blood pressure between 120-159 mmHg OR diastolic blood pressure between 80-99 mmHg. Can be on >=1 antihypertensive medications if on stable dose for past 3 months - Systolic blood pressure <120 mmHg OR diastolic blood pressure <80 mmHg, if on stable dose of >=1 antihypertensive medications for past 3 months Exclusion Criteria (Blood Pressure): - Elevated blood pressure: Systolic blood pressure >=160 mmHg OR diastolic blood pressure >=100 mmHg Exclusion Criteria (Underlying medical conditions/diseases): - Have had a heart attack, stroke, coronary heart disease, congestive heart failure, or angina - Have had coronary artery bypass surgery or cardiac catheterization such as percutaneous transluminal coronary angioplasty (PTCA), cath or stent placement - Have diabetes - Have medical contraindications to regular, unsupervised physical activity - Have moderate to severe asthma, or chronic obstructive pulmonary disorder (also called emphysema or chronic bronchitis) - Had cancer in the past 5 years (except non-melanoma skin cancer) - Currently under medical care for digestive issues, gastrointestinal distress, abdominal pain, or diarrhea - Had an organ transplant Exclusion Criteria (Medications): - Not stable on medications over the past 3 months (e.g., cholesterol, thyroid, estrogen-hormone, psychiatric) - Currently taking prescription pain medications (e.g., Vicodin, Oxycodone) Exclusion Criteria (Weight and diet related): - Have binge eating disorder or bulimic compensatory symptoms - Currently taking medication designed to lose weight - Have undergone weight-loss surgery (e.g., gastric bypass, lap band) - Have lost >10 pounds in the past 6 months - Currently in a weight-loss program (e.g., Jenny Craig) - Currently participating in any support groups that focus on weight or eating habits (e.g., Overeaters Anonymous) - Currently on a special diet for a serious health condition - Not willing to discontinue a special diet (e.g., Atkins) Exclusion Criteria (Behavioral related): - Planning to move in the next year - Currently pregnant or planning to be within the next year - Participating in another research study - No regular access to a mobile phone and Internet - Not able to speak, read, or understand English for informed consent - Not willing to be randomized - Did not complete eligibility process successfully or in a timely manner - Staff discretion or judgement - Live within Bay Area (e.g., ~1-hour commute from Stanford research center) |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in self-reported enjoyment of healthy lifestyle behaviors from 0-2 months | Participants will rate their enjoyment of four key healthy lifestyle behaviors (healthy eating, physical activity, weighing, self-nurturing) via online survey at 0, 2, 6, 12, 24, and 36 months [Change in enjoyment from 0-2 months is the mediator in the efficacy model] | Baseline to 2 months | |
Other | Incremental cost-effectiveness ratio (U.S. Dollars per quality-adjusted life-years) of either weight-management intervention versus no intervention | Participants will self-report their work productivity, costs, and quality-of-life via online surveys [Ratio will be based on changes in productivity, costs, and quality-adjusted life-years over the life course in the simulated cost-effectiveness model, see below for three self-reported measures incorporated into model] | Baseline to 36 months | |
Other | Change in self-reported work productivity and activity from 6-36 months | Participants will report their work productivity and activity using the Work Productivity and Activity Impairment Questionnaire via online survey at 6, 12, 24, and 36 months | 6 to 36 months | |
Other | Change in self-reported costs of participating in the weight-management interventions from 6-36 months | Participants will rate their costs of participating in the weight-management interventions via online survey at 6, 12, 24, and 36 months | 6 to 36 months | |
Other | Change in self-reported quality of life from 0-36 months | Participants will rate their quality of life using the Short Form Health Survey (SF-36) via online survey at 0, 6, 12, 24, and 36 months | Baseline to 36 months | |
Other | Change in weight in kilograms from 0-36 months, assessed by clinic scales | Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months | Baseline to 36 months | |
Other | Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by clinic scales | Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months | Baseline to 36 months | |
Other | Change in weight in kilograms from 0-36 months, assessed by cellular scales | Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time | Baseline to 36 months | |
Other | Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by cellular scales | Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time | Baseline to 36 months | |
Primary | Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (i.e., Lose >=7% of their initial body weight from 0-12 months AND gain <=5 lbs from 12-36 months), assessed by clinic scales | Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months | Baseline to 36 months | |
Secondary | Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (Lose >=7% of their initial body weight from 0-12 months AND gain <=5 lbs from 12-36 months), assessed by cellular scales | Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time | Baseline to 36 months | |
Secondary | Change in systolic blood pressure from 0-36 months | Participants will have their systolic blood pressure assessed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months | Baseline to 36 months |
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