Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic

Completed · Not applicable

Conditions studied: Obesity

In brief

The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics. To achieve these goals, the investigators will pursue the following Specific Aims: Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups. Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants. Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks. Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.

Key facts

Study ID

NCT03202420

Run by

Duke University

People needed

26

Starts

2017-12-22

Expected to finish

2019-12-05

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be patients of the DOC.
• BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).

You may not qualify if…

• Mental illness that would cause disruptions to group meetings
• Cognitive impairment that would preclude participants from understanding the program
• Type 2 diabetics on insulin or sulfonylureas without provider approval
• untreated hyper- or hypothyroidism
• current cancer diagnosis
• history of cancer (other than skin cancer)
• gastrointestinal disorders affecting food intake
• use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
• women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
• weight loss of > 5% in past 6 months
• major psychiatric disorder
• current moderate to severe symptoms of depression
• eating disorders
• current alcohol or substance abuse.

Where it is running

• Duke General Internal Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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