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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

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

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

NCT ID

NCT01558297

First Posted

March 15, 2012

Last Updated

June 3, 2015

Sponsor

Yale University

Collaborators

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

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

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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