Behavioral Program for Weight Loss Maintenance

HW
Overseen ByHolly Wyatt, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new weight loss maintenance program for individuals discontinuing anti-obesity medications. It features a 10-week core program and tests additional supports such as meal plans, gym access, and meditation. The goal is to identify which combination best helps maintain weight loss. Individuals who have recently lost at least 15% of their body weight with medication and are ready to stop the medication may be suitable candidates. Participants should be comfortable with moderate exercise and have reliable internet access for virtual sessions. As an unphased trial, this study provides a unique opportunity to explore innovative weight maintenance strategies without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

Yes, you will need to stop taking anti-obesity medications before joining the trial, as continued use after randomization is not allowed.

What prior data suggests that this behavioral program is safe for weight loss maintenance?

Research shows that the components of the weight loss maintenance program under study are safe to use.

For Mom's Meals, evidence indicates that meals tailored for medical needs are safe and can enhance health. They adhere to strict food safety and quality standards.

The SKY Meditation program is generally safe and manageable. Studies have shown it can reduce stress and enhance mental health.

YMCA membership promotes physical activity, a safe and effective method for aiding weight loss and improving overall health.

These elements have been used elsewhere without major safety issues. Based on previous research, participants in this trial can expect a safe experience.12345

Why are researchers excited about this trial?

Researchers are excited about this weight loss maintenance program because it combines various supportive components to enhance long-term success in maintaining weight loss. Unlike standard options that might focus solely on diet or exercise, this program integrates medically tailored meals, YMCA memberships for physical activity, and the SKY Meditation program for mental well-being. By adopting a holistic approach, this program aims to address the physical, nutritional, and psychological aspects of weight management, potentially offering more comprehensive support than traditional methods.

What evidence suggests that this trial's treatments could be effective for weight loss maintenance?

This trial will evaluate various combinations of support components for weight loss maintenance. Participants in different groups will receive the foundational Weight Loss Maintenance (WLM) Program along with additional components. Studies have shown that meals specifically designed for medical needs, such as those provided by Mom's Meals, can improve health by reducing hospital visits and lowering healthcare costs. Home-delivered meals can also promote better eating habits and may assist with weight loss. Research indicates that mindfulness practices, like the SKY Meditation program, help maintain weight by reducing stress and making it easier to adhere to a diet. YMCA membership programs have been linked to better eating habits and increased physical activity, which can lead to weight loss. Together, these elements support weight maintenance by focusing on diet, exercise, and mental well-being.15678

Who Is on the Research Team?

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Holly Wyatt, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have lost at least 15% of their body weight using anti-obesity medication, recently stopped or plan to stop the medication, regained no more than about 7 pounds in the last 3 months, can attend study visits and virtual sessions, speak English, have internet access, and are cleared by a doctor for moderate exercise and diet changes.

Inclusion Criteria

I am 18 years old or older.
I am willing to attend all required study visits and assessments.
I have lost at least 15% of my body weight with weight loss medication.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week foundational weight loss maintenance program with various support components

10 weeks
Weekly sessions

Follow-up

Participants are monitored for retention and adherence, with assessments at 3 and 6 months

6 months
Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mom's Meals
  • SKY Meditation Program
  • Weight Loss Maintenance Program (Foundational)
  • YMCA Membership

Trial Overview

The study tests different combinations of support programs to help people keep weight off after stopping anti-obesity medications. These include a core 10-week program plus options like healthy meal delivery, YMCA membership for physical activity, and a structured meditation course. Participants are randomly assigned to various combinations over six months.

How Is the Trial Designed?

8

Treatment groups

Active Control

Group I: Group 1: WLM Program + Mom's Meals + YMCA + SKYActive Control4 Interventions
Group II: Group 2: WLM Program + Mom's Meals + YMCAActive Control3 Interventions
Group III: Group 3: WLM Program + Mom's Meals + SKYActive Control3 Interventions
Group IV: Group 4: WLM Program + Mom's MealsActive Control2 Interventions
Group V: Group 5: WLM Program + YMCA + SKYActive Control3 Interventions
Group VI: Group 6: WLM Program + YMCAActive Control2 Interventions
Group VII: Group 7: WLM Program + SKYActive Control2 Interventions
Group VIII: Group 8: Foundational WLM Program OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

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