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Internet Treatment for Weight Loss in Primary Care

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ClinicalTrials.gov Identifier: NCT01558297
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : June 4, 2015
Last Update Posted : July 1, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rachel D. Barnes, Yale University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Overweight Obese Behavioral: Motivational Interviewing Behavioral: Nutritional Counseling Behavioral: Treatment as usual with primary care physician Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Treatment for Weight Loss in Primary Care
Study Start Date : April 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Motivational Interviewing Behavioral: Motivational Interviewing
5 sessions of motivational interviewing over a period of 3 months.
Active Comparator: Nutritional Counseling Behavioral: Nutritional Counseling
5 sessions of nutritional counseling over a period of 3 months.
Active Comparator: Treatment as usual Behavioral: Treatment as usual with primary care physician
Participants will be encouraged to continue their care with their primary care physician.



Primary Outcome Measures :
  1. 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.

  2. 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. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558297


Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rachel Barnes, PhD Yale University

Publications of Results:
Responsible Party: Rachel D. Barnes, Associate Research Scienist, Yale University
ClinicalTrials.gov Identifier: NCT01558297     History of Changes
Other Study ID Numbers: 1106008713
1K23DK092279-01 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2012    Key Record Dates
Results First Posted: June 4, 2015
Last Update Posted: July 1, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes