New Media Obesity Treatment in Community Health Centers

Duke University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: eHealth weight loss intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01827800

B0033

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 351 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 2 patient groups

eHealth weight loss intervention

Experimental group

Description:

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.

Treatment:

Behavioral: eHealth weight loss intervention

Usual care

No Intervention group

Description:

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