Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care

Obesity Clinical Trial

Official title:

Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578199
• Other study ID #: 1106008713-B
• Secondary ID: R03DK104008-01
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 10, 2017

Study information

• Verified date: November 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Motivational interviewing and nutritional counseling for weight loss in primary care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 10, 2017
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• motivational interviewing and nutrition
Motivational Interviewing and Nutritional Counseling

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight in Pounds	Body weight in pounds measured 3 months after starting treatment.	3 months
Secondary	Body Weight in Pounds	Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).	6 months