Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Obesity, Primary Care, Lifestyle Intervention
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.
Interventions
BEHAVIORALIn 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.
BEHAVIORALTelephone 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.
BEHAVIORALMedical 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change From Baseline | Baseline, 6, 12, 24, and 36 months. | Percent weight change form baseline; negative values indicate weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c: Change From Baseline | 6, 12, 24 months | Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline. |
| Systolic Blood Pressure: Change From Baseline | 6, 12, 24, months. | Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement. |
| Triglyceride Levels: Change From Baseline | 6, 12, 24 months | Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline. |
| Diet Self-efficacy: Change From Baseline | 6, 12, 24, and 36 months. | 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 |
| Dietary Restraint: Change From Baseline | Baseline, 6, 12, 24, and 36 months. | 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. |
| Diabetes Distress: Change From Baseline | Baseline, 6, 12, 24, and 36 months. | 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 |
| Depression Score: Change From Baseline. | Baseline, 6, 12, 24, and 36 months. | 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. |
| Fat-related Diet Behavior: Change From Baseline. | Baseline, 6, 12, 24, and 36 months. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Economics | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
Actual enrollment 211
Participants by arm
| Arm | Count |
|---|---|
| Medical Nutrition Therapy (MNT) 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).
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. | 66 |
| In Person Group (IP) 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.
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. | 70 |
| Telephone Conference Call Group (TCC) 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.
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. | 72 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | Total |
|---|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 10.7 | 61.3 years STANDARD_DEVIATION 10.3 | 62.4 years STANDARD_DEVIATION 9.8 | 61.7 years STANDARD_DEVIATION 10.2 |
| Diabetes Distress | 36.9 score STANDARD_DEVIATION 23.1 | 39.3 score STANDARD_DEVIATION 19.5 | 40.3 score STANDARD_DEVIATION 23.3 | 38.9 score STANDARD_DEVIATION 22 |
| Dietary restraint | 2.8 units on a scale STANDARD_DEVIATION 0.6 | 2.9 units on a scale STANDARD_DEVIATION 0.6 | 2.8 units on a scale STANDARD_DEVIATION 0.8 | 2.8 units on a scale STANDARD_DEVIATION 0.7 |
| Diet self efficacy scale | 3.7 units on a scale STANDARD_DEVIATION 0.6 | 3.6 units on a scale STANDARD_DEVIATION 0.7 | 3.8 units on a scale STANDARD_DEVIATION 0.7 | 3.7 units on a scale STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 10 Participants | 7 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 60 Participants | 65 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fat-related diet behavior | 2.7 units on a scale STANDARD_DEVIATION 0.6 | 2.7 units on a scale STANDARD_DEVIATION 0.5 | 2.8 units on a scale STANDARD_DEVIATION 0.6 | 2.7 units on a scale STANDARD_DEVIATION 0.6 |
| Hemoglobin A1c | 7.8 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 | 7.8 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 | 7.6 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.1 | 7.7 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.2 |
| Mood | 5.3 units on a scale STANDARD_DEVIATION 5.4 | 4.7 units on a scale STANDARD_DEVIATION 4.4 | 4.4 units on a scale STANDARD_DEVIATION 3.8 | 4.8 units on a scale STANDARD_DEVIATION 4.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 10 Participants | 10 Participants | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 55 Participants | 58 Participants | 160 Participants |
| Region of Enrollment United States | 66 participants | 70 participants | 72 participants | 208 participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 41 Participants | 115 Participants |
| Sex: Female, Male Male | 29 Participants | 33 Participants | 31 Participants | 93 Participants |
| Systolic blood pressure | 125 mmHg STANDARD_DEVIATION 16 | 126 mmHg STANDARD_DEVIATION 14 | 124 mmHg STANDARD_DEVIATION 10 | 125 mmHg STANDARD_DEVIATION 14 |
| Triglycerides | 146 mg/dl STANDARD_DEVIATION 99 | 196 mg/dl STANDARD_DEVIATION 290 | 152 mg/dl STANDARD_DEVIATION 94 | 165 mg/dl STANDARD_DEVIATION 186 |
| Weight | 99.7 kg STANDARD_DEVIATION 21.4 | 98.8 kg STANDARD_DEVIATION 17 | 96.1 kg STANDARD_DEVIATION 18.2 | 98.7 kg STANDARD_DEVIATION 18.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 66 | 0 / 70 | 1 / 72 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 18 / 66 | 16 / 70 | 12 / 72 |
Outcome results
Primary
Percent Weight Change From Baseline
Percent weight change form baseline; negative values indicate weight loss.
Time frame: Baseline, 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Percent Weight Change From Baseline | Six months | -1.1 percentage of weight | Standard Deviation 3.7 |
| Medical Nutrition Therapy (MNT) | Percent Weight Change From Baseline | Twelve months | -2.0 percentage of weight | Standard Deviation 4.1 |
| Medical Nutrition Therapy (MNT) | Percent Weight Change From Baseline | Twenty-four months | -3.1 percentage of weight | Standard Deviation 5.2 |
| Medical Nutrition Therapy (MNT) | Percent Weight Change From Baseline | Thirty-six months | -5.8 percentage of weight | Standard Deviation 7.1 |
| In Person Group (IP) | Percent Weight Change From Baseline | Thirty-six months | -4.4 percentage of weight | Standard Deviation 5.4 |
| In Person Group (IP) | Percent Weight Change From Baseline | Six months | -5.6 percentage of weight | Standard Deviation 4.9 |
| In Person Group (IP) | Percent Weight Change From Baseline | Twenty-four months | -4.4 percentage of weight | Standard Deviation 5.9 |
| In Person Group (IP) | Percent Weight Change From Baseline | Twelve months | -4.5 percentage of weight | Standard Deviation 6.1 |
| Telephone Conference Call Group (TCC) | Percent Weight Change From Baseline | Thirty-six months | -5.3 percentage of weight | Standard Deviation 6.4 |
| Telephone Conference Call Group (TCC) | Percent Weight Change From Baseline | Twelve months | -4.8 percentage of weight | Standard Deviation 6.1 |
| Telephone Conference Call Group (TCC) | Percent Weight Change From Baseline | Twenty-four months | -4.0 percentage of weight | Standard Deviation 5.8 |
| Telephone Conference Call Group (TCC) | Percent Weight Change From Baseline | Six months | -4.6 percentage of weight | Standard Deviation 5.8 |
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.
Time frame: Baseline, 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Depression Score: Change From Baseline. | Six months | -0.6 score on a scale | Standard Deviation 4.5 |
| Medical Nutrition Therapy (MNT) | Depression Score: Change From Baseline. | Twelve months | -0.9 score on a scale | Standard Deviation 4.1 |
| Medical Nutrition Therapy (MNT) | Depression Score: Change From Baseline. | Twenty-four months | -1.0 score on a scale | Standard Deviation 4.3 |
| Medical Nutrition Therapy (MNT) | Depression Score: Change From Baseline. | Thirty-six months | -0.9 score on a scale | Standard Deviation 5.2 |
| In Person Group (IP) | Depression Score: Change From Baseline. | Thirty-six months | -0.7 score on a scale | Standard Deviation 3.7 |
| In Person Group (IP) | Depression Score: Change From Baseline. | Six months | -1.0 score on a scale | Standard Deviation 3.3 |
| In Person Group (IP) | Depression Score: Change From Baseline. | Twenty-four months | -0.8 score on a scale | Standard Deviation 3.2 |
| In Person Group (IP) | Depression Score: Change From Baseline. | Twelve months | -1.2 score on a scale | Standard Deviation 2.8 |
| Telephone Conference Call Group (TCC) | Depression Score: Change From Baseline. | Thirty-six months | 0.2 score on a scale | Standard Deviation 4.3 |
| Telephone Conference Call Group (TCC) | Depression Score: Change From Baseline. | Twelve months | -0.4 score on a scale | Standard Deviation 3.7 |
| Telephone Conference Call Group (TCC) | Depression Score: Change From Baseline. | Twenty-four months | -0.1 score on a scale | Standard Deviation 3.1 |
| Telephone Conference Call Group (TCC) | Depression Score: Change From Baseline. | Six months | -0.7 score on a scale | Standard Deviation 3.1 |
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
Time frame: Baseline, 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Diabetes Distress: Change From Baseline | Six months | -7.0 score on a scale | Standard Deviation 17.6 |
| Medical Nutrition Therapy (MNT) | Diabetes Distress: Change From Baseline | Twelve months | -5.8 score on a scale | Standard Deviation 18 |
| Medical Nutrition Therapy (MNT) | Diabetes Distress: Change From Baseline | Twenty-four months | -9.2 score on a scale | Standard Deviation 22.8 |
| Medical Nutrition Therapy (MNT) | Diabetes Distress: Change From Baseline | Thirty-six months | -13.4 score on a scale | Standard Deviation 22.9 |
| In Person Group (IP) | Diabetes Distress: Change From Baseline | Thirty-six months | -14.1 score on a scale | Standard Deviation 17.8 |
| In Person Group (IP) | Diabetes Distress: Change From Baseline | Six months | -12.4 score on a scale | Standard Deviation 20.3 |
| In Person Group (IP) | Diabetes Distress: Change From Baseline | Twenty-four months | -13.0 score on a scale | Standard Deviation 15.3 |
| In Person Group (IP) | Diabetes Distress: Change From Baseline | Twelve months | -14.4 score on a scale | Standard Deviation 15 |
| Telephone Conference Call Group (TCC) | Diabetes Distress: Change From Baseline | Thirty-six months | -14.3 score on a scale | Standard Deviation 18.6 |
| Telephone Conference Call Group (TCC) | Diabetes Distress: Change From Baseline | Twelve months | -15.1 score on a scale | Standard Deviation 21.9 |
| Telephone Conference Call Group (TCC) | Diabetes Distress: Change From Baseline | Twenty-four months | -16.3 score on a scale | Standard Deviation 20 |
| Telephone Conference Call Group (TCC) | Diabetes Distress: Change From Baseline | Six months | -14.1 score on a scale | Standard Deviation 19.4 |
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.
Time frame: Baseline, 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Dietary Restraint: Change From Baseline | Twenty-four months | 0.3 score on a scale | Standard Deviation 0.7 |
| Medical Nutrition Therapy (MNT) | Dietary Restraint: Change From Baseline | Six months | 0.4 score on a scale | Standard Deviation 0.7 |
| Medical Nutrition Therapy (MNT) | Dietary Restraint: Change From Baseline | Thirty six months | 0.4 score on a scale | Standard Deviation 0.4 |
| Medical Nutrition Therapy (MNT) | Dietary Restraint: Change From Baseline | Twelve months | 0.5 score on a scale | Standard Deviation 0.7 |
| In Person Group (IP) | Dietary Restraint: Change From Baseline | Twenty-four months | 0.7 score on a scale | Standard Deviation 0.7 |
| In Person Group (IP) | Dietary Restraint: Change From Baseline | Twelve months | 0.5 score on a scale | Standard Deviation 0.6 |
| In Person Group (IP) | Dietary Restraint: Change From Baseline | Six months | 0.6 score on a scale | Standard Deviation 0.6 |
| In Person Group (IP) | Dietary Restraint: Change From Baseline | Thirty six months | 0.7 score on a scale | Standard Deviation 0.7 |
| Telephone Conference Call Group (TCC) | Dietary Restraint: Change From Baseline | Thirty six months | 0.4 score on a scale | Standard Deviation 0.8 |
| Telephone Conference Call Group (TCC) | Dietary Restraint: Change From Baseline | Six months | 0.6 score on a scale | Standard Deviation 0.7 |
| Telephone Conference Call Group (TCC) | Dietary Restraint: Change From Baseline | Twelve months | 0.5 score on a scale | Standard Deviation 0.7 |
| Telephone Conference Call Group (TCC) | Dietary Restraint: Change From Baseline | Twenty-four months | 0.6 score on a scale | Standard Deviation 0.6 |
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
Time frame: 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Diet Self-efficacy: Change From Baseline | Six months | -0.2 score on a scale | Standard Deviation 0.7 |
| Medical Nutrition Therapy (MNT) | Diet Self-efficacy: Change From Baseline | Twelve months | -0.3 score on a scale | Standard Deviation 0.8 |
| Medical Nutrition Therapy (MNT) | Diet Self-efficacy: Change From Baseline | Twenty-four months | -0.2 score on a scale | Standard Deviation 0.8 |
| Medical Nutrition Therapy (MNT) | Diet Self-efficacy: Change From Baseline | Thirty-six months | -0.1 score on a scale | Standard Deviation 0.9 |
| In Person Group (IP) | Diet Self-efficacy: Change From Baseline | Thirty-six months | -0.1 score on a scale | Standard Deviation 0.9 |
| In Person Group (IP) | Diet Self-efficacy: Change From Baseline | Six months | 0.3 score on a scale | Standard Deviation 0.7 |
| In Person Group (IP) | Diet Self-efficacy: Change From Baseline | Twenty-four months | 0.3 score on a scale | Standard Deviation 0.7 |
| In Person Group (IP) | Diet Self-efficacy: Change From Baseline | Twelve months | 0.2 score on a scale | Standard Deviation 0.8 |
| Telephone Conference Call Group (TCC) | Diet Self-efficacy: Change From Baseline | Thirty-six months | -0.4 score on a scale | Standard Deviation 0.8 |
| Telephone Conference Call Group (TCC) | Diet Self-efficacy: Change From Baseline | Twelve months | -0.1 score on a scale | Standard Deviation 0.8 |
| Telephone Conference Call Group (TCC) | Diet Self-efficacy: Change From Baseline | Twenty-four months | -0.1 score on a scale | Standard Deviation 0.8 |
| Telephone Conference Call Group (TCC) | Diet Self-efficacy: Change From Baseline | Six months | 0.1 score on a scale | Standard Deviation 0.6 |
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
Time frame: Baseline, 6, 12, 24, and 36 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Fat-related Diet Behavior: Change From Baseline. | Six months | -0.1 score on a scale | Standard Deviation 0.4 |
| Medical Nutrition Therapy (MNT) | Fat-related Diet Behavior: Change From Baseline. | Twelve months | -0.2 score on a scale | Standard Deviation 0.4 |
| Medical Nutrition Therapy (MNT) | Fat-related Diet Behavior: Change From Baseline. | Twenty-four months | -0.2 score on a scale | Standard Deviation 0.4 |
| Medical Nutrition Therapy (MNT) | Fat-related Diet Behavior: Change From Baseline. | Thirty-six months | -0.3 score on a scale | Standard Deviation 0.5 |
| In Person Group (IP) | Fat-related Diet Behavior: Change From Baseline. | Thirty-six months | -0.3 score on a scale | Standard Deviation 0.4 |
| In Person Group (IP) | Fat-related Diet Behavior: Change From Baseline. | Six months | -0.4 score on a scale | Standard Deviation 0.5 |
| In Person Group (IP) | Fat-related Diet Behavior: Change From Baseline. | Twenty-four months | -0.4 score on a scale | Standard Deviation 0.4 |
| In Person Group (IP) | Fat-related Diet Behavior: Change From Baseline. | Twelve months | -0.4 score on a scale | Standard Deviation 0.5 |
| Telephone Conference Call Group (TCC) | Fat-related Diet Behavior: Change From Baseline. | Thirty-six months | -0.3 score on a scale | Standard Deviation 0.4 |
| Telephone Conference Call Group (TCC) | Fat-related Diet Behavior: Change From Baseline. | Twelve months | -0.3 score on a scale | Standard Deviation 0.5 |
| Telephone Conference Call Group (TCC) | Fat-related Diet Behavior: Change From Baseline. | Twenty-four months | -0.4 score on a scale | Standard Deviation 0.5 |
| Telephone Conference Call Group (TCC) | Fat-related Diet Behavior: Change From Baseline. | Six months | -0.3 score on a scale | Standard Deviation 0.5 |
Secondary
Hemoglobin A1c: Change From Baseline
Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline.
Time frame: 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Hemoglobin A1c: Change From Baseline | Twelve months | -0.4 units of HbA1c (%) | Standard Deviation 1.2 |
| Medical Nutrition Therapy (MNT) | Hemoglobin A1c: Change From Baseline | Six months | -0.3 units of HbA1c (%) | Standard Deviation 1.1 |
| Medical Nutrition Therapy (MNT) | Hemoglobin A1c: Change From Baseline | Twenty-four months | -0.2 units of HbA1c (%) | Standard Deviation 1.4 |
| In Person Group (IP) | Hemoglobin A1c: Change From Baseline | Twelve months | -0.4 units of HbA1c (%) | Standard Deviation 0.8 |
| In Person Group (IP) | Hemoglobin A1c: Change From Baseline | Six months | -0.6 units of HbA1c (%) | Standard Deviation 0.8 |
| In Person Group (IP) | Hemoglobin A1c: Change From Baseline | Twenty-four months | -0.3 units of HbA1c (%) | Standard Deviation 1.3 |
| Telephone Conference Call Group (TCC) | Hemoglobin A1c: Change From Baseline | Six months | -0.5 units of HbA1c (%) | Standard Deviation 1.2 |
| Telephone Conference Call Group (TCC) | Hemoglobin A1c: Change From Baseline | Twenty-four months | 0.1 units of HbA1c (%) | Standard Deviation 1.4 |
| Telephone Conference Call Group (TCC) | Hemoglobin A1c: Change From Baseline | Twelve months | -0.2 units of HbA1c (%) | Standard Deviation 1.3 |
Secondary
Systolic Blood Pressure: Change From Baseline
Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.
Time frame: 6, 12, 24, months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Systolic Blood Pressure: Change From Baseline | Twelve months | 1.8 mmHg | Standard Deviation 16 |
| Medical Nutrition Therapy (MNT) | Systolic Blood Pressure: Change From Baseline | Six months | 0 mmHg | Standard Deviation 14.7 |
| Medical Nutrition Therapy (MNT) | Systolic Blood Pressure: Change From Baseline | Twenty-four months | -0.6 mmHg | Standard Deviation 16 |
| In Person Group (IP) | Systolic Blood Pressure: Change From Baseline | Twelve months | -1.8 mmHg | Standard Deviation 16 |
| In Person Group (IP) | Systolic Blood Pressure: Change From Baseline | Six months | -4.0 mmHg | Standard Deviation 15 |
| In Person Group (IP) | Systolic Blood Pressure: Change From Baseline | Twenty-four months | -3.5 mmHg | Standard Deviation 15 |
| Telephone Conference Call Group (TCC) | Systolic Blood Pressure: Change From Baseline | Six months | -2.3 mmHg | Standard Deviation 14 |
| Telephone Conference Call Group (TCC) | Systolic Blood Pressure: Change From Baseline | Twenty-four months | -3.3 mmHg | Standard Deviation 15 |
| Telephone Conference Call Group (TCC) | Systolic Blood Pressure: Change From Baseline | Twelve months | -1.0 mmHg | Standard Deviation 15 |
Secondary
Triglyceride Levels: Change From Baseline
Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline.
Time frame: 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medical Nutrition Therapy (MNT) | Triglyceride Levels: Change From Baseline | Twenty-four months | -8.6 mg/dl | Standard Deviation 71 |
| Medical Nutrition Therapy (MNT) | Triglyceride Levels: Change From Baseline | Six months | 12.5 mg/dl | Standard Deviation 80 |
| Medical Nutrition Therapy (MNT) | Triglyceride Levels: Change From Baseline | Twelve months | 7.9 mg/dl | Standard Deviation 76 |
| In Person Group (IP) | Triglyceride Levels: Change From Baseline | Twelve months | -57.4 mg/dl | Standard Deviation 259 |
| In Person Group (IP) | Triglyceride Levels: Change From Baseline | Twenty-four months | -31.8 mg/dl | Standard Deviation 228 |
| In Person Group (IP) | Triglyceride Levels: Change From Baseline | Six months | -56.0 mg/dl | Standard Deviation 253 |
| Telephone Conference Call Group (TCC) | Triglyceride Levels: Change From Baseline | Six months | -21.3 mg/dl | Standard Deviation 81 |
| Telephone Conference Call Group (TCC) | Triglyceride Levels: Change From Baseline | Twenty-four months | -4.1 mg/dl | Standard Deviation 86 |
| Telephone Conference Call Group (TCC) | Triglyceride Levels: Change From Baseline | Twelve months | -1.1 mg/dl | Standard Deviation 114 |
Other Pre-specified
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Medical Nutrition Therapy (MNT) | Health Economics | 591 US Dollar |
| In Person Group (IP) | Health Economics | 1390 US Dollar |
| Telephone Conference Call Group (TCC) | Health Economics | 1814 US Dollar |