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

NCT01713764 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-12-30

No results posted yet for this study

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.

Conditions

  • Diabetes Type II

Interventions

BEHAVIORAL

Low Carbohydrate Diet

BEHAVIORAL

American Diabetes Association Diet

BEHAVIORAL

Mindfulness and Positive Affect Skills

Sponsors & Collaborators

Principal Investigators

  • Frederick M Hecht, M.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713764 on ClinicalTrials.gov