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

Obesity Clinical Trial

— TOPS at DOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202420
• Other study ID #: Pro00080518
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: December 5, 2019

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight Changes
• Obesity

Intervention

Other:
• TOPS
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.

Locations

Country	Name	City	State
United States	Duke General Internal Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Program Attendance	Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).	52 Weeks
Secondary	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