CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 211 enrolled
Drug / intervention
In Person Group (IP) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02320253N/ACompleted
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REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes

Massachusetts General Hospital·interventional·Posted Dec 19, 2014·Updated Sep 20, 2021

In Brief

A clinical study evaluating In Person Group (IP), Telephone Conference Call Group (TCC), and 1 other intervention for Type 2 Diabetes Mellitus and Obesity. Completed, enrolled 211 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Obesity
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 19, 2014
Enrollment StartNov 1, 2014
Primary CompletionSep 1, 2020
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.5 years ago

Interventions

In Person Group (IP)behavioral

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.

Telephone Conference Call Group (TCC)behavioral

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.

Medical Nutrition Therapy (MNT)behavioral

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