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OpenTrials
Completed

NCT Number: NCT01827800

New Media Obesity Treatment in Community Health Centers

This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
  • BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
  • Diagnosis of hypertension or diabetes

Exclusion criteria

  • Current pregnancy
  • Pregnancy in previous 12 months
  • Heart attack/stroke in previous 2 years
  • Active cancer diagnosis
  • Current participation in another weight loss study

Treatment and study plan

eHealth weight loss intervention

Behavioral

This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers.

Primary outcomes

  1. Weight change

    Time frame: Baseline - 12 months

    Weight will be measured at baseline and 12 months using a SECA 876 scale.

Secondary outcomes

  1. The achievement and maintenance of > 5% weight loss

    Time frame: Baseline - 12 months

    Weight will be measured at baseline and 12 months using a SECA 876 scale.

  2. Diet

    Time frame: Baseline - 12 months

    Dietary assessments will be performed at baseline and 12 months using the ASA24, a self-administered dietary recall measure developed by the National Cancer Institute.

  3. Cardiometabolic risk markers

    Time frame: Baseline - 12 months

    Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels

  4. Global Framingham risk score

    Time frame: Baseline - 12 months

    The Framingham Risk Score is a validated scoring system used to determine an individual's chances of developing cardiovascular disease. We will calculate this score at baseline and 12 months.

  5. An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework

    Time frame: 12 and 24 months

    RE-AIM was originally developed as a framework for consistent reporting of research results and later used to organize reviews of the existing literature on health promotion and disease management in different settings. The acronym stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance which together determine public health impact. More recently, RE-AIM has been used to translate research into practice and to help plan programs and improve their chances of working in "real-world" settings. The framework has also been used to understand the relative strengths and weaknesses of different approaches to health promotion and chronic disease self-management-such as in-person counseling, group education classes, telephone counseling, and internet resources.

  6. Physical activity

    Time frame: Baseline -12 months

    Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Apr 10, 2013
Registry last updated
Aug 13, 2018

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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