Clinical trial NCT02578199: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-10-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body Weight in Pounds
timeFrame: 3 months
Secondary outcomes:
measure: Body Weight in Pounds
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Rachel Barnes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.