Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care

March 26, 2020 updated by: Yale University
Motivational interviewing and nutritional counseling for weight loss in primary care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.

Study Type

Interventional

Enrollment (Actual)

31

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

  • United States
    • 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
  • Recruited through local primary care offices.
  • Age 18-65

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/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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: motivational interviewing and nutrition
Motivational interviewing and nutritional counseling.
Behavioral: motivational interviewing and nutrition
Motivational Interviewing and Nutritional Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight in Pounds
Time Frame: 3 months
Body weight in pounds measured 3 months after starting treatment.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight in Pounds
Time Frame: 6 months
Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Rachel Barnes, Ph.D., Yale School of Medicine

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

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

December 1, 2015

Primary Completion (Actual)

December 2, 2016

Study Completion (Actual)

March 10, 2017

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106008713-B
  • R03DK104008-01 (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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