Internet Treatment for Weight Loss in Primary Care

Overweight Clinical Trial

Official title:

Internet Treatment for Weight Loss in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558297
• Other study ID #: 1106008713
• Secondary ID: 1K23DK092279-01
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: June 3, 2015
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Behavioral:
• Motivational Interviewing
5 sessions of motivational interviewing over a period of 3 months.
• Nutritional Counseling
5 sessions of nutritional counseling over a period of 3 months.
• Treatment as usual with primary care physician
Participants will be encouraged to continue their care with their primary care physician.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight in Pounds.	Body weight lost in pounds measured 1.5 months after first treatment session.	1.5 months after treatment start (Baseline)	No
Primary	Body Weight in Pounds.	Body weight lost in pounds measured 3 months after first treatment session.	3 months after treatment start (Baseline)	No
Primary	Body Weight in Pounds.	Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).	6 months after treatment start (Baseline)	No