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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320253
• Other study ID #: 2014P002074
• Secondary ID: 1R18DK102737-01A
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2021

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 standard of care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: July 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Charlestown HealthCare Center	Charlestown	Massachusetts
United States	Chelsea HealthCare Center	Chelsea	Massachusetts
United States	Revere HealthCare Center	Revere	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Economics	Total cost of intervention at 12 months taking into account intervention cost and savings from medication dose reduction. Incremental cost effectiveness and probabilistic sensitivity analyses and further details are reported in: 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: 31965526; PMCID: PMC7458982.	12 months
Primary	Percent Weight Change From Baseline	Percent weight change form baseline; negative values indicate weight loss.	Baseline, 6, 12, 24, and 36 months.
Secondary	Hemoglobin A1c: Change From Baseline	Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline.	6, 12, 24 months
Secondary	Systolic Blood Pressure: Change From Baseline	Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.	6, 12, 24, months.
Secondary	Triglyceride Levels: Change From Baseline	Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline.	6, 12, 24 months
Secondary	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	6, 12, 24, and 36 months.
Secondary	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	Baseline, 6, 12, 24, and 36 months.
Secondary	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.	Baseline, 6, 12, 24, and 36 months.
Secondary	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	Baseline, 6, 12, 24, and 36 months.
Secondary	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.	Baseline, 6, 12, 24, and 36 months.