This trial is active, not recruiting.

Conditions overweight, obese
Treatments motivational interviewing, nutritional counseling, treatment as usual with primary care physician
Sponsor Yale University
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date April 2012
End date August 2016
Trial size 87 participants
Trial identifier NCT01558297, 1106008713, 1K23DK092279-01


This study will test the effectiveness of two distinct treatments for weight loss:

1. Motivational Interviewing

2. Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
motivational interviewing
5 sessions of motivational interviewing over a period of 3 months.
(Active Comparator)
nutritional counseling
5 sessions of nutritional counseling over a period of 3 months.
(Active Comparator)
treatment as usual with primary care physician
Participants will be encouraged to continue their care with their primary care physician.

Primary Outcomes

body weight in pounds.
time frame: 1.5 months after treatment start
body weight in pounds.
time frame: 3 months
body weight in pounds.
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - BMI 25-55 - Daily access to internet and phone 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 or 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

Additional Information

Official title Internet Treatment for Weight Loss in Primary Care
Principal investigator Rachel Barnes, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Yale University.