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Internet Treatment for Weight Loss in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558297
First Posted: March 20, 2012
Last Update Posted: July 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rachel D. Barnes, Yale University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Rachel D. Barnes, Yale University:

Primary Outcome Measures:
  • 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.

  • Body Weight in Pounds. [ Time Frame: 3 months after treatment start (Baseline) ]
    Body weight lost in pounds measured 3 months after first treatment session.

  • 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).


Enrollment: 89
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
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 Submitted: March 15, 2012
First Posted: March 20, 2012
Results First Submitted: May 19, 2015
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