Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
motivational interviewing and nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
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
Sites / Locations
- Yale School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
motivational interviewing and nutrition
Arm Description
Motivational interviewing and nutritional counseling.
Outcomes
Primary Outcome Measures
Body Weight in Pounds
Body weight in pounds measured 3 months after starting treatment.
Secondary Outcome Measures
Body Weight in Pounds
Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).
Full Information
NCT ID
NCT02578199
First Posted
October 14, 2015
Last Updated
March 26, 2020
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02578199
Brief Title
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
Official Title
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
March 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Motivational interviewing and nutritional counseling for weight loss in primary care.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motivational interviewing and nutrition
Arm Type
Experimental
Arm Description
Motivational interviewing and nutritional counseling.
Intervention Type
Behavioral
Intervention Name(s)
motivational interviewing and nutrition
Intervention Description
Motivational Interviewing and Nutritional Counseling
Primary Outcome Measure Information:
Title
Body Weight in Pounds
Description
Body weight in pounds measured 3 months after starting treatment.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body Weight in Pounds
Description
Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).
Time Frame
6 months
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Barnes, Ph.D.
Organizational Affiliation
Yale School of Medicine
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
32894453
Citation
Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. 12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care. Eat Weight Disord. 2021 Aug;26(6):2077-2081. doi: 10.1007/s40519-020-00994-5. Epub 2020 Sep 7.
Results Reference
derived
PubMed Identifier
29275778
Citation
Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. Examining motivational interviewing plus nutrition psychoeducation for weight loss in primary care. J Psychosom Res. 2018 Jan;104:101-107. doi: 10.1016/j.jpsychores.2017.11.013. Epub 2017 Nov 28.
Results Reference
derived
PubMed Identifier
29086484
Citation
Barnes RD, Ivezaj V, Martino S, Pittman BP, Grilo CM. Back to Basics? No Weight Loss from Motivational Interviewing Compared to Nutrition Psychoeducation at One-Year Follow-Up. Obesity (Silver Spring). 2017 Dec;25(12):2074-2078. doi: 10.1002/oby.21972. Epub 2017 Oct 31.
Results Reference
derived
Learn more about this trial
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
We'll reach out to this number within 24 hrs