NCT02320253

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 20, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

5.8 years

First QC Date

December 10, 2014

Results QC Date

July 26, 2021

Last Update Submit

September 17, 2021

Conditions

Type 2 Diabetes MellitusObesity

Keywords

DiabetesObesityPrimary CareLifestyle Intervention

Outcome Measures

Primary Outcomes (1)

  • Percent Weight Change From Baseline

    Percent weight change form baseline; negative values indicate weight loss.

    Baseline, 6, 12, 24, and 36 months.

Secondary Outcomes (8)

  • Hemoglobin A1c: Change From Baseline

    6, 12, 24 months

  • Systolic Blood Pressure: Change From Baseline

    6, 12, 24, months.

  • Triglyceride Levels: Change From Baseline

    6, 12, 24 months

  • Diet Self-efficacy: Change From Baseline

    6, 12, 24, and 36 months.

  • Fat-related Diet Behavior: Change From Baseline.

    Baseline, 6, 12, 24, and 36 months.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Health Economics

    12 months

Study Arms (3)

Medical Nutrition Therapy (MNT)

ACTIVE COMPARATOR

Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s).

Behavioral: Medical Nutrition Therapy (MNT)

In Person Group (IP)

EXPERIMENTAL

Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.

Behavioral: In Person Group (IP)

Telephone Conference Call Group (TCC)

EXPERIMENTAL

Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year.

Behavioral: Telephone Conference Call Group (TCC)

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.

In Person Group (IP)
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.

Telephone Conference Call Group (TCC)
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.

Medical Nutrition Therapy (MNT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes
  • Age 18 years or older
  • Overweight or obese (BMI \>25 kg/m2)
  • HbA1c level 6.5\<11.5%
  • Systolic blood pressure (SBP) \<160 mmHg, diastolic blood pressure (DBP) \<100 mmHg
  • Willing to lose 5-7% of body weight
  • Willing to increase activity to at least 175 minutes/week
  • Willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to Nutrition Services for medical nutrition therapy
  • Stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
  • Ability to understand and communicate effectively in English or Spanish
  • Willing to self-monitor blood glucose
  • Willing to keep a food, exercise, and blood glucose diary
  • Have a primary care physician at MGH Chelsea, Charlestown, or Revere Health Centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider

You may not qualify if:

  • Weight greater than 350 pounds
  • Pregnant or planning pregnancy in the next year
  • Currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program and unwilling to stop
  • Weight change of more than 3% of weight in the previous month.
  • Currently enrolled in another diabetes intervention study
  • Lack of availability of telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Charlestown HealthCare Center

Charlestown, Massachusetts, 02129, United States

Location

Chelsea HealthCare Center

Chelsea, Massachusetts, 02150, United States

Location

Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Location

Related Publications (6)

  • Delahanty LM, Chang Y, Levy DE, Porneala B, Dushkin A, Bissett L, Goldman V, Perrotta J, Rodriguez AR, Chase B, LaRocca R, Wheeler A, Wexler DJ. Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The REAL HEALTH-diabetes study. Contemp Clin Trials. 2018 Aug;71:9-17. doi: 10.1016/j.cct.2018.05.018. Epub 2018 May 25.

    PMID: 29803816BACKGROUND

  • Vakharia JD, Thaweethai T, Licht P, Wexler DJ, Delahanty LM. Psychological and Behavioral Predictors of Weight Loss in the Reach Ahead for Lifestyle and Health-Diabetes Lifestyle Intervention Cohort. J Acad Nutr Diet. 2023 Jul;123(7):1033-1043.e1. doi: 10.1016/j.jand.2023.02.018. Epub 2023 Mar 5.

    PMID: 36871848DERIVED

  • Wexler DJ, Chang Y, Levy DE, Porneala B, McCarthy J, Rodriguez Romero A, Goldman V, Copeland PM, Steppel-Reznik J, Delahanty LM. Results of a 2-year lifestyle intervention for type 2 diabetes: the Reach Ahead for Lifestyle and Health-Diabetes randomized controlled trial. Obesity (Silver Spring). 2022 Oct;30(10):1938-1950. doi: 10.1002/oby.23508. Epub 2022 Aug 31.

    PMID: 36046939DERIVED

  • Berkowitz SA, Chang Y, Porneala B, Cromer SJ, Wexler DJ, Delahanty LM. Does the effect of lifestyle intervention for individuals with diabetes vary by food insecurity status? A preplanned subgroup analysis of the REAL HEALTH randomized clinical trial. BMJ Open Diabetes Res Care. 2020 Sep;8(1):e001514. doi: 10.1136/bmjdrc-2020-001514.

    PMID: 32978121DERIVED

  • Delahanty LM, Levy DE, Chang Y, Porneala BC, Goldman V, McCarthy J, Bissett L, Rodriguez AR, Chase B, LaRocca R, Wheeler A, Wexler DJ. Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. J Gen Intern Med. 2020 Sep;35(9):2637-2646. doi: 10.1007/s11606-019-05629-9. Epub 2020 Jan 21.

    PMID: 31965526DERIVED

  • Goldman V, Dushkin A, Wexler DJ, Chang Y, Porneala B, Bissett L, McCarthy J, Rodriguez A, Chase B, LaRocca R, Wheeler A, Delahanty LM. Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study. Contemp Clin Trials Commun. 2019 May 1;15:100374. doi: 10.1016/j.conctc.2019.100374. eCollection 2019 Sep.

    PMID: 31193095DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes Mellitus

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Dr. Deborah J. Wexler
Organization
MGH Diabetes Center
dwexler@mgh.harvard.edu
617-726-8767

Study Officials

  • Linda M Delahanty, MS RD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Deborah J Wexler, MSc MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Dietitian at Massachusetts General Hospital Diabetes Center

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 19, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2020

Study Completion

July 1, 2021

Last Updated

September 20, 2021

Results First Posted

September 20, 2021

Record last verified: 2021-09

Locations

US(4)