New Media Obesity Treatment in Community Health Centers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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eHealth weight loss intervention

The 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling.

Group Type EXPERIMENTAL

eHealth weight loss intervention

Intervention Type 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.

Usual care

Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eHealth weight loss intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No