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

NCT03202420 | Completed

• 1 other identifier: Pro00080518
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Program Attendance

  52 Weeks

• Retention as measured by attendance sheets

  12, 24 and 52 weeks

Study Arms (1)

TOPS

EXPERIMENTAL

Participants will attend weekly TOPS meetings with standard weekly weigh ins

Other: TOPS

Interventions

TOPS OTHER

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.

TOPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke General Internal Medicine

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

TOPS

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nia S Mitchell, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: December 22, 2017
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)