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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK102737-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change From Baseline | Percent weight change form baseline; negative values indicate weight loss. | Baseline, 6, 12, 24, and 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c: Change From Baseline | Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline. | 6, 12, 24 months |
| Systolic Blood Pressure: Change From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda M Delahanty, MS RD | Massachusetts General Hospital | Principal Investigator |
| Deborah J Wexler, MSc MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Charlestown HealthCare Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29803816 | Background | 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. | |
| 36871848 | Derived | 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. |
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Actual enrollment 211
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Three participants from the MNT arm withdrew consent and were not analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Weight Change From Baseline | Percent weight change form baseline; negative values indicate weight loss. | Posted | Mean | Standard Deviation | percentage of weight | Baseline, 6, 12, 24, and 36 months. |
|
3 years
SAEs were collected according to standard definitions (hospitalized events, death, etc). Other Adverse events were not monitored/addressed in this lifestyle intervention study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission | General disorders | Systematic Assessment | For this lifestyle intervention study, we tracked al hospital admissions as SAEs. None of the SAEs were deemed to be related to the intervention. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah J. Wexler | MGH Diabetes Center | 617-726-8767 | dwexler@mgh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2020 | Jul 23, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.
| 6, 12, 24, months. |
| Triglyceride Levels: Change From Baseline | Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline. | 6, 12, 24 months |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 12 months |
| Charlestown |
| Massachusetts |
| 02129 |
| United States |
| Chelsea HealthCare Center | Chelsea | Massachusetts | 02150 | United States |
| Revere HealthCare Center | Revere | Massachusetts | 02151 | United States |
| 36046939 | Derived | 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. |
| 32978121 | Derived | 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. |
| 31965526 | Derived | 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. |
| 31193095 | Derived | 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. |
| Death |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Boston, MA, USA and surrounding communities | Number | participants |
|
| Weight | Weight is measured in kilograms. | Mean | Standard Deviation | kg |
|
| Hemoglobin A1c | Mean | Standard Deviation | Percentage of glycated hemoglobin |
|
| Systolic blood pressure | Systolic blood pressure is measured in mmHg | Mean | Standard Deviation | mmHg |
|
| Triglycerides | Mean | Standard Deviation | mg/dl |
|
| Diet self efficacy scale | The Diet Self-Efficacy Scale ranges from 1-5 with higher scores denoting greater self confidence in measuring diet. Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-efficacy. Nursing research. 1992;41(6):347-51. | Mean | Standard Deviation | units on a scale |
|
| Fat-related diet behavior | Fat-related diet behavior is graded from 1-5, in which lower scores indicate lower fat dietary habits. 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):214-20. | Mean | Standard Deviation | units on a scale |
|
| Dietary restraint | 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. | Mean | Standard Deviation | units on a scale |
|
| Diabetes Distress | Diabetes distress was measured with the Problem Areas in Diabetes Scale, in which higher scores indicate greater emotional distress on a scale of 1 to 100, 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 | Mean | Standard Deviation | score |
|
| Mood | The PHQ-8 measures depressed mood, with higher scores representing a higher degree of depressed mood and negative values indicating improvement. 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. | Mean | Standard Deviation | units on a scale |
|
| 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. |
| OG002 | 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. |
|
|
| Secondary | Hemoglobin A1c: Change From Baseline | Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline. | Posted | Mean | Standard Deviation | units of HbA1c (%) | 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. | Posted | Mean | Standard Deviation | mmHg | 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. | Posted | Mean | Standard Deviation | mg/dl | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6, 12, 24, and 36 months. |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | US Dollar | 12 months |
|
|
|
| 1 |
| 66 |
| 18 |
| 66 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 70 | 16 | 70 | 0 | 0 |
| EG002 | 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. | 1 | 72 | 12 | 72 | 0 | 0 |
|
Not provided
Not provided
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Twenty-four months |
|
|
| Twenty-four months |
|
|
| Twenty-four months |
|
|
| Twenty-four months |
|
| Thirty-six months |
|
|
| Twenty-four months |
|
| Thirty-six months |
|
|
| Twenty-four months |
|
| Thirty six months |
|
|
| Twenty-four months |
|
| Thirty-six months |
|
|
| Twenty-four months |
|
| Thirty-six months |
|