REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes

Summary

The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 2 diabetes and obesity into usual care at community health centers, comparing an in-person group program (IP), a telephone conference call (TCC) group program, and referral to medical nutrition therapy (MNT), the current standard of care.

Conditions

• Type 2 Diabetes Mellitus
• Obesity

Interventions

BEHAVIORAL

In Person Group (IP)

The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success.

BEHAVIORAL

Telephone Conference Call Group (TCC)

The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention.

BEHAVIORAL

Medical Nutrition Therapy (MNT)

Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Linda M Delahanty, MS RD · Massachusetts General Hospital

• Deborah J Wexler, MSc MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2020-09-30

Completion

2021-07-31

Countries

• United States

Study Locations