- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01558297
Internet Treatment for Weight Loss in Primary Care
June 3, 2015 updated by: Rachel D. Barnes, Yale University
This study will test the effectiveness of two distinct treatments for weight loss:
- Motivational Interviewing
- Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
|
Participants will be encouraged to continue their care with their primary care physician.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight in Pounds.
Time Frame: 1.5 months after treatment start (Baseline)
|
Body weight lost in pounds measured 1.5 months after first treatment session.
|
1.5 months after treatment start (Baseline)
|
Body Weight in Pounds.
Time Frame: 3 months after treatment start (Baseline)
|
Body weight lost in pounds measured 3 months after first treatment session.
|
3 months after treatment start (Baseline)
|
Body Weight in Pounds.
Time Frame: 6 months after treatment start (Baseline)
|
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).
|
6 months after treatment start (Baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rachel Barnes, PhD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9.
- Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 15, 2012
First Submitted That Met QC Criteria
March 16, 2012
First Posted (Estimate)
March 20, 2012
Study Record Updates
Last Update Posted (Estimate)
July 1, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1106008713
- 1K23DK092279-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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