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Internet Treatment for Weight Loss in Primary Care

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Nutritional Counseling
Treatment as usual with primary care physician
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Motivational Interviewing

Nutritional Counseling

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Body Weight in Pounds.
Body weight lost in pounds measured 1.5 months after first treatment session.
Body Weight in Pounds.
Body weight lost in pounds measured 3 months after first treatment session.
Body Weight in Pounds.
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).

Secondary Outcome Measures

Full Information

First Posted
March 15, 2012
Last Updated
June 3, 2015
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01558297
Brief Title
Internet Treatment for Weight Loss in Primary Care
Official Title
Internet Treatment for Weight Loss in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test the effectiveness of two distinct treatments for weight loss: Motivational Interviewing Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Title
Nutritional Counseling
Arm Type
Active Comparator
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
5 sessions of motivational interviewing over a period of 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention Description
5 sessions of nutritional counseling over a period of 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual with primary care physician
Intervention Description
Participants will be encouraged to continue their care with their primary care physician.
Primary Outcome Measure Information:
Title
Body Weight in Pounds.
Description
Body weight lost in pounds measured 1.5 months after first treatment session.
Time Frame
1.5 months after treatment start (Baseline)
Title
Body Weight in Pounds.
Description
Body weight lost in pounds measured 3 months after first treatment session.
Time Frame
3 months after treatment start (Baseline)
Title
Body Weight in Pounds.
Description
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).
Time Frame
6 months after treatment start (Baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Barnes, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25298016
Citation
Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9.
Results Reference
result
PubMed Identifier
31816053
Citation
Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149.
Results Reference
derived

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Internet Treatment for Weight Loss in Primary Care

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