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Type 2 Diabetes MellitusNCT02320253

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

A study testing In Person Group (IP), Telephone Conference Call Group (TCC) and Medical Nutrition Therapy (MNT) in people with Type 2 Diabetes Mellitus and Obesity, run by Massachusetts General Hospital at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
In Person Group (IP), Telephone Conference Call Group (TCC) and Medical Nutrition Therapy (MNT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
4 sitesUnited States
Study dates
Nov 2014to Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Charlestown HealthCare Center

    Charlestown, Massachusetts, 02129

  • Chelsea HealthCare Center

    Chelsea, Massachusetts, 02150

  • Revere HealthCare Center

    Revere, Massachusetts, 02151

Other trials in United States

About this study

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.

Read the detailed description

Participants will be randomly assigned to one of three arms: MNT, IP, or TCC. Participants will be enrolled in the study for a total of three years. During those three years, participants will have 5 research visits, at baseline, where randomization occurs, 6 months, 12 months, 24 months, and 36 months. At each research visit, participants will have a lipid panel and HbA1c sample drawn, their blood pressure, weight, and height, baseline only, taken. Participants will also answer questionnaires that will address health behaviors, self-efficacy, measures of self-determination, depression, literacy and numeracy, food insecurity, health-related quality-of-life and patient satisfaction with quality of care.

For the group-based interventions, dietitians will deliver the adapted Look AHEAD lifestyle intervention. The first 14 sessions will be delivered weekly and the next 5 sessions biweekly. In the subsequent 18 months, group sessions will be delivered monthly from 6-24 months. In addition, participants will be offered up to 5 individual MNT sessions over the 2 year intervention period. At these individual visits, dietitians will address diabetes-related issues and discuss tailored goals and behaviors, based on the Look AHEAD model. Dietitians will provide ongoing feedback to participants' own PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss strategies with their patients. Each group will contain up to 12 participants with type 2 diabetes and will last 1-1.5 hours. 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 addition to the teaching component, participants who are taking insulin or medications that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and submit self-monitoring records for review each week, either by delivering them at the in-person sessions or by mailing, faxing, or emailing them to the study team. Patients on oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do targeted monitoring to determine the effects of exercise and meals on blood glucose. The study provider at each health center will review BG records and make any needed adjustments to insulin or medication doses according to an algorithm to maintain glycemic control and prevent hypoglycemia as participants lose weight.

A trained member of the study staff will provide MNT referral participants with an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes and schedule them for an appointment with a dietitian from Nutrition Services for follow up.

Being tested
In Person Group (IP), Telephone Conference Call Group (TCC), Medical Nutrition Therapy (MNT)
Keywords
Diabetes, Obesity, Primary Care, Lifestyle Intervention
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In Person Group (IP)Behavioural

    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)Behavioural

    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)Behavioural

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

Study groups in NCT02320253
Study groupRoleWhat they receive
Medical Nutrition Therapy (MNT)Active comparatorParticipants 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).
Receives: Behavioral: Medical Nutrition Therapy (MNT)
In Person Group (IP)ExperimentalParticipants 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.
Receives: Behavioral: In Person Group (IP)
Telephone Conference Call Group (TCC)ExperimentalParticipants 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.
Receives: Behavioral: Telephone Conference Call Group (TCC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Weight Change From Baseline

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

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

Secondary outcomes (8)

  1. Hemoglobin A1c: Change From Baseline

    Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline.

    Measured: 6, 12, 24 months

  2. Systolic Blood Pressure: Change From Baseline

    Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.

    Measured: 6, 12, 24, months.

  3. Triglyceride Levels: Change From Baseline

    Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline.

    Measured: 6, 12, 24 months

  4. Diet Self-efficacy: Change From Baseline

    Diet Self-Efficacy Scale is scored 1-5 with higher scores denoting greater self confidence in managing diet and positive values denoting improved self-confidence in managing diet. Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-efficacy. Nursing research. 1992;41(6):347-351

    Measured: 6, 12, 24, and 36 months.

  5. Fat-related Diet Behavior: Change From Baseline.

    Fat-related diet behavior was scored on a scale of 1 to 5, in which lower scores indicate lower fat dietary habits. Negative values indicate a shift to lower-fat diet behavior.

    Kristal AR, Shattuck AL, Henry HJ. Patterns of dietary behavior associated with selecting diets low in fat: reliability and validity of a behavioral approach to dietary assessment. J Am Diet Assoc. 1990;90(2):214-220.

    Glasgow RE, Perry JD, Toobert DJ, Hollis JF. Brief assessments of dietary behavior in field settings. Addictive behaviors. 1996;21(2):239-247

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

  6. Dietary Restraint: Change From Baseline

    Dietary restraint was measured by the Dutch Eating Behavior Questionnaire with higher scores (1-5) denoting greater self-regulation of dietary behaviors and positive values denoting improved dietary restraint. Van Strien T, Frijters JER, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders. 1986;5(2):295-315.

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

  7. Diabetes Distress: Change From Baseline

    Diabetes distress was measured with the Problem Areas in Diabetes Scale. The scale ranges from 0 to 100, in which higher scores indicate greater emotional distress, with a score of 40 marking the threshold for severe emotional distress. Negative values indicate reduction in diabetes-related distress.

    Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997;20(5):760-766

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

  8. Depression Score: Change From Baseline.

    The PHQ-8 measures depressed mood, with higher scores representing a higher degree of depressed mood and negative values indicating improvement. The range of scores is 0 to 24. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163-173.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionSep 2020
  4. Study completionJul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320253
Sponsor's protocol ID
2014P002074
Other IDs
1R18DK102737-01A1
Status last verified
Sep 2021
First submitted
10 Dec 2014
Last updated
20 Sep 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29803816

  • 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.

    PubMed 36871848

  • 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.

    PubMed 36046939

  • 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.

    PubMed 32978121

  • 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.

    PubMed 31965526

  • 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.

    PubMed 31193095

Questions about this trial

What is this clinical trial studying?

A study testing In Person Group (IP), Telephone Conference Call Group (TCC) and Medical Nutrition Therapy (MNT) in people with Type 2 Diabetes Mellitus and Obesity, run by Massachusetts General Hospital at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Change From Baseline (time frame: Baseline, 6, 12, 24, and 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320253, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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