Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: motivational interviewing and nutrition

• Registration Number: NCT02578199
• Lead Sponsor: Yale University

Brief Summary

Motivational interviewing and nutritional counseling for weight loss in primary care.

Detailed Description

Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.

Study Timeline

• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Study Start: 2015-12
• Status Verified: 2016-11
• Primary Completion: 2016-12-02
• Study Completion: 2017-03-10
• Results First Submitted: 2017-06-13
• Results First Submitted QC: 2017-06-13
• Results First Posted: 2017-08-01
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• BMI 25-55
• Daily access to internet and phone
• Recruited through local primary care offices.
• Age 18-65

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Exclusion Criteria

• Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
• Meets criteria for current substance abuse/dependence
• Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
• Pregnant, breastfeeding, or plans to become pregnant during the treatment period
• Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
• Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
• Uncontrolled diabetes, thyroid conditions, or hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
motivational interviewing and nutrition	motivational interviewing and nutrition	Motivational interviewing and nutritional counseling.

Primary Outcome Measures

Name	Time	Method
Body Weight in Pounds	3 months	Body weight in pounds measured 3 months after starting treatment.

Secondary Outcome Measures

Name	Time	Method
Body Weight in Pounds	6 months	Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States