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Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will use their assigned package for 12 months."
  • "Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests which mix of support methods best helps adults with obesity keep weight off. Everyone starts with a 16-week weight loss program. Those who lose at least 5% of their weight move on to 12 months of care, with zero to four support methods chosen by chance.

The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. * The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. * The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have a body mass index (BMI) over 30. BMI is a measure based on height and weight.
  • Have regular internet access to use Zoom.
  • If asked during screening, be willing to get your healthcare provider’s approval to exercise before joining.

Who can't join

  • Used prescription weight loss medicine in the past 6 months, or lost more than 10 pounds in that time unless it was after childbirth.
  • Are pregnant or expect to become pregnant.
  • Have a household member in this study, or are in another study that assigns groups by chance.
  • Have uncontrolled high blood pressure: above 160/100 at screening.
  • Had a heart attack, stroke, or unstable angina (chest pain) in the past 6 months; have severe heart failure (NYHA class III or IV), type 1 diabetes, or long-term lung disease that limits activity.
  • Cannot name an adult friend or family member who could be your support buddy.
  • Live more than 50 miles from the university, or plan to move out of the area within 18 months.
  • Have no internet access, or cannot or will not give informed consent (agree after learning about the study), read and understand English, or accept a group chosen by chance.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age \>18 years * Body mass index (BMI) \>30 kg/m2 * Has regular access to internet (to access Zoom videoconferencing platform) * If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment Exclusion Criteria: * Current or recent (past 6 months) use of prescription weight loss medications * Weight loss \>10 pounds in past 6 months (other than postpartum) * Pregnancy or anticipating pregnancy * Another household member already participating in the study * Participation in another randomized research project * Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening) * Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last 6 months; unstable angina within the past 6 months; NYHA Class III or IV congestive heart failure; type 1 diabetes; and chronic lung diseases that limit physical activity * Unable to identify potential buddy (i.e., adult friend or family member) for extended care intervention phase * Residing \>50 miles from the university (to attend assessment visits) * Planning to relocate out of the area in the next 18 months * Does not have internet access * Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment

Study sites (1)

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