NCT01713764

A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.

Detailed description

Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Conditions

• Diabetes Type II

Interventions

Type	Name	Description
BEHAVIORAL	Low Carbohydrate Diet
BEHAVIORAL	American Diabetes Association Diet
BEHAVIORAL	Mindfulness and Positive Affect Skills

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-25
• Last updated: 2013-12-30

Locations

1 site across 1 country: United States