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Completed

NCT Number: NCT03202420

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke General Internal Medicine

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 12, 24, and 52 weeks

    Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.

Secondary outcomes

  1. Program Attendance

    Time frame: 52 Weeks

    Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).

  2. Retention as measured by attendance sheets

    Time frame: 12, 24 and 52 weeks

    Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: TOPS at DOC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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