Comparing Weight Loss Programs for Adults with Obesity

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a BMI of 25 or higher who want to lose weight, own a smartphone, and are not already in a weight loss program.

Age

Over 18 years old.

Sex

All sexes can join.

Disease stage

BMI of 25 or higher and weight under 396 lbs (180 kg).

Earlier treatment

Must not be enrolled in a formal weight loss program. Must not be taking weight loss medications, such as GLP-1 agonists.

Main reasons for not taking part

• Stroke or heart attack within six months of enrollment
• Diabetes treated with insulin
• Pregnancy, breastfeeding or planned pregnancy
• Active suicidal thoughts
• Anorexia or bulimia

The registry criteria, word for word

What the trial wants to find out

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

The 3 groups in the trial

• Adaptive SMARTer intervention (SMARTer)Treatment being tested

  Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Data from a wifi scale will be monitored. Individuals losing less than .5 lb per week will be stepped up to also be given meal replacement products. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.

• Diabetes Prevention Program (DPP)Treatment being tested

  Fixed intervention using participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.

• Self-Guided Treatment (Self-Guided)Existing treatment, for comparison

  Provides paper and internet resources tailored to geographic area, educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.