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Internet Treatment for Weight Loss in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rachel D. Barnes, Yale University
ClinicalTrials.gov Identifier:
NCT01558297
First received: March 15, 2012
Last updated: June 19, 2013
Last verified: June 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558297

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Rachel Barnes, PhD Yale University
  More Information

No publications provided

Responsible Party: Rachel D. Barnes, Associate Research Scienist, Yale University
ClinicalTrials.gov Identifier: NCT01558297     History of Changes
Other Study ID Numbers: 1106008713, 1K23DK092279-01
Study First Received: March 15, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014