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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Other: TOPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOPS<br>Participants will attend weekly TOPS meetings with standard weekly weigh ins | Other: TOPS<br>* Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks. | Baseline, 12, 24, and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Attendance | Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered). | 52 Weeks | 
| Retention as measured by attendance sheets | Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks. | 12, 24 and 52 weeks |