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Internet Treatment for Weight Loss in Primary Care

This study is currently recruiting participants.
Verified May 2012 by Yale University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01558297
First received: March 15, 2012
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Overweight
Obese
 Behavioral: Motivational Interviewing
Behavioral: Nutritional Counseling
Behavioral: Treatment as usual with primary care physician

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Treatment for Weight Loss in Primary Care

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • body weight in pounds. [ Time Frame: 1.5 months after treatment start ] [ Designated as safety issue: No ]
    Body weight in pounds measured 1.5 months after starting treatment.

  • body weight in pounds. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body weight in pounds measured 3 months after starting treatment.

  • body weight in pounds. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).


Estimated Enrollment: 87
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558297

Contacts
Contact: Lorri Ovryn, Ph.D. (203) 737-5537 lorri.ovryn@yale.edu

Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Lorri Ovryn, Ph.D.     203-737-5537     lorri.ovryn@yale.edu    
Contact: Rachel Barnes, Ph.D.         rachel.barnes@yale.edu    
Principal Investigator: Rachel Barnes, Ph.D.            
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rachel Barnes, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01558297     History of Changes
Other Study ID Numbers: 1106008713, 1K23DK092279-01
Study First Received: March 15, 2012
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013