Clinical trial NCT02320253: REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Official title: REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: Diabetes
Obesity
Primary Care
Lifestyle Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-12-19
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent Weight Change From Baseline
timeFrame: Baseline, 6, 12, 24, and 36 months.
Secondary outcomes:
measure: Hemoglobin A1c: Change From Baseline
timeFrame: 6, 12, 24 months
measure: Systolic Blood Pressure: Change From Baseline
timeFrame: 6, 12, 24, months.
measure: Triglyceride Levels: Change From Baseline
timeFrame: 6, 12, 24 months
measure: Diet Self-efficacy: Change From Baseline
timeFrame: 6, 12, 24, and 36 months.
measure: Fat-related Diet Behavior: Change From Baseline.
timeFrame: Baseline, 6, 12, 24, and 36 months.
measure: Dietary Restraint: Change From Baseline
timeFrame: Baseline, 6, 12, 24, and 36 months.
measure: Diabetes Distress: Change From Baseline
timeFrame: Baseline, 6, 12, 24, and 36 months.
measure: Depression Score: Change From Baseline.
timeFrame: Baseline, 6, 12, 24, and 36 months.
Other outcomes:
measure: Health Economics
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Charlestown
country: United States
facility: Charlestown HealthCare Center
state: Massachusetts
city: Chelsea
country: United States
facility: Chelsea HealthCare Center
state: Massachusetts
city: Revere
country: United States
facility: Revere HealthCare Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Linda M Delahanty, MS RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Deborah J Wexler, MSc MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.