Small Changes Program for Obesity

Recruiting at 1 trial location

Overseen By Juan Aguilera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Anti-obesity, Diabetes medications

Disqualifiers: Pregnancy, Kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

52 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any anti-obesity or diabetes medications that induce weight loss, such as GLP-1RAs, to participate.

What data supports the effectiveness of the Small Changes treatment for obesity?

The Small Changes program showed better weight loss results over 12 months compared to the existing MOVE! program at two Veterans Affairs sites, indicating its potential effectiveness for managing obesity. ^{1 2 3 4 5}

Is the Small Changes Program for Obesity safe for humans?

The Small Changes Program, which involves making small adjustments to diet and physical activity, has been tested in adults with overweight and obesity. The research did not report any significant safety concerns, suggesting it is generally safe for humans. ^{3 6 7 8 9}

How does the Small Changes treatment for obesity differ from other treatments?

The Small Changes treatment for obesity focuses on making gradual, manageable adjustments in diet and physical activity rather than large, immediate changes. This approach aims to prevent further weight gain and gradually reduce obesity rates over time, making it different from traditional programs that often require significant lifestyle overhauls. ^{1 3 5 8 10}

What is the purpose of this trial?

The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance

Research Team

Leah Whigham, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with a BMI of 25 or higher who've maintained a stable weight recently, are willing to follow a diet plan, live in the study area, can attend appointments every two weeks, and have their doctor's okay to lose weight. It's not for pregnant women, those with recent commercial dieting history, eating disorders, severe dietary restrictions due to allergies, serious health conditions like kidney or liver disease or cancer; nor people who've had bariatric surgery or take certain diabetes medications.

Inclusion Criteria

Body Mass Index greater than or equal to 25

Stable weight with less than a 5% body weight change in the past 3 months

Willingness and ability to follow a written dietary plan

Exclusion Criteria

Pregnant or lactating

History of commercial weight loss program participation within the last six months

History of anorexia nervosa or other eating disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Small Changes program or standard behavioral therapy for weight loss

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Small Changes program

Trial Overview The trial is testing if the Small Changes program helps people lose weight better than standard behavioral therapy. Participants will be monitored over 12 weeks to see changes in body composition, metabolic health markers in blood tests and blood pressure levels. The study also looks at how many stick with it and follow the rules.

Participant Groups

Group I: Small Changes program Experimental Treatment 1 Intervention

Group II: Standard behavioral therapy for weight loss Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Improving Dietary Recommendations for Patients With Type 2 Diabetes and Obesity in an Endocrinology Clinic. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. [2012]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Linking care of patients with obesity to outpatient weight control clinics following acute hospitalizations. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a physician-delivered weight management programme. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: A Randomized Clinical Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A small change approach on adiposity, lean mass and bone mineral density in adults with overweight and obesity: A randomized controlled trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Weight change from 3-year observational data: findings from the worldwide schizophrenia outpatient health outcomes database. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. [2023]