Trial Outcomes & Findings for REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes (NCT NCT02320253)
NCT ID: NCT02320253
Last Updated: 2021-09-20
Results Overview
Percent weight change form baseline; negative values indicate weight loss.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Baseline, 6, 12, 24, and 36 months.
Results posted on
2021-09-20
Participant Flow
Actual enrollment 211
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
72
|
|
Overall Study
COMPLETED
|
63
|
68
|
70
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
Baseline Characteristics
REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Baseline characteristics by cohort
| Measure |
Medical Nutrition Therapy (MNT)
n=66 Participants
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.
|
In Person Group (IP)
n=70 Participants
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.
|
Telephone Conference Call Group (TCC)
n=72 Participants
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.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
70 participants
n=7 Participants
|
72 participants
n=5 Participants
|
208 participants
n=4 Participants
|
|
Weight
|
99.7 kg
STANDARD_DEVIATION 21.4 • n=5 Participants
|
98.8 kg
STANDARD_DEVIATION 17.0 • n=7 Participants
|
96.1 kg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
98.7 kg
STANDARD_DEVIATION 18.9 • n=4 Participants
|
|
Hemoglobin A1c
|
7.8 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.8 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.2 • n=7 Participants
|
7.6 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
7.7 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Systolic blood pressure
|
125 mmHg
STANDARD_DEVIATION 16 • n=5 Participants
|
126 mmHg
STANDARD_DEVIATION 14 • n=7 Participants
|
124 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
125 mmHg
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Triglycerides
|
146 mg/dl
STANDARD_DEVIATION 99 • n=5 Participants
|
196 mg/dl
STANDARD_DEVIATION 290 • n=7 Participants
|
152 mg/dl
STANDARD_DEVIATION 94 • n=5 Participants
|
165 mg/dl
STANDARD_DEVIATION 186 • n=4 Participants
|
|
Diet self efficacy scale
|
3.7 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Fat-related diet behavior
|
2.7 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Dietary restraint
|
2.8 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Diabetes Distress
|
36.9 score
STANDARD_DEVIATION 23.1 • n=5 Participants
|
39.3 score
STANDARD_DEVIATION 19.5 • n=7 Participants
|
40.3 score
STANDARD_DEVIATION 23.3 • n=5 Participants
|
38.9 score
STANDARD_DEVIATION 22.0 • n=4 Participants
|
|
Mood
|
5.3 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 4.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 12, 24, and 36 months.Percent weight change form baseline; negative values indicate weight loss.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=63 Participants
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.
|
In Person Group (IP)
n=68 Participants
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.
|
Telephone Conference Call Group (TCC)
n=70 Participants
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.
|
|---|---|---|---|
|
Percent Weight Change From Baseline
Six months
|
-1.1 percentage of weight
Standard Deviation 3.7
|
-5.6 percentage of weight
Standard Deviation 4.9
|
-4.6 percentage of weight
Standard Deviation 5.8
|
|
Percent Weight Change From Baseline
Twelve months
|
-2.0 percentage of weight
Standard Deviation 4.1
|
-4.5 percentage of weight
Standard Deviation 6.1
|
-4.8 percentage of weight
Standard Deviation 6.1
|
|
Percent Weight Change From Baseline
Twenty-four months
|
-3.1 percentage of weight
Standard Deviation 5.2
|
-4.4 percentage of weight
Standard Deviation 5.9
|
-4.0 percentage of weight
Standard Deviation 5.8
|
|
Percent Weight Change From Baseline
Thirty-six months
|
-5.8 percentage of weight
Standard Deviation 7.1
|
-4.4 percentage of weight
Standard Deviation 5.4
|
-5.3 percentage of weight
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 6, 12, 24 monthsChange in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=65 Participants
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.
|
In Person Group (IP)
n=68 Participants
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.
|
Telephone Conference Call Group (TCC)
n=70 Participants
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.
|
|---|---|---|---|
|
Hemoglobin A1c: Change From Baseline
Six months
|
-0.3 units of HbA1c (%)
Standard Deviation 1.1
|
-0.6 units of HbA1c (%)
Standard Deviation 0.8
|
-0.5 units of HbA1c (%)
Standard Deviation 1.2
|
|
Hemoglobin A1c: Change From Baseline
Twelve months
|
-0.4 units of HbA1c (%)
Standard Deviation 1.2
|
-0.4 units of HbA1c (%)
Standard Deviation 0.8
|
-0.2 units of HbA1c (%)
Standard Deviation 1.3
|
|
Hemoglobin A1c: Change From Baseline
Twenty-four months
|
-0.2 units of HbA1c (%)
Standard Deviation 1.4
|
-0.3 units of HbA1c (%)
Standard Deviation 1.3
|
0.1 units of HbA1c (%)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6, 12, 24, months.Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=66 Participants
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.
|
In Person Group (IP)
n=68 Participants
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.
|
Telephone Conference Call Group (TCC)
n=70 Participants
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.
|
|---|---|---|---|
|
Systolic Blood Pressure: Change From Baseline
Six months
|
0 mmHg
Standard Deviation 14.7
|
-4.0 mmHg
Standard Deviation 15
|
-2.3 mmHg
Standard Deviation 14
|
|
Systolic Blood Pressure: Change From Baseline
Twelve months
|
1.8 mmHg
Standard Deviation 16
|
-1.8 mmHg
Standard Deviation 16
|
-1.0 mmHg
Standard Deviation 15
|
|
Systolic Blood Pressure: Change From Baseline
Twenty-four months
|
-0.6 mmHg
Standard Deviation 16
|
-3.5 mmHg
Standard Deviation 15
|
-3.3 mmHg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 6, 12, 24 monthsTriglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=61 Participants
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.
|
In Person Group (IP)
n=66 Participants
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.
|
Telephone Conference Call Group (TCC)
n=70 Participants
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.
|
|---|---|---|---|
|
Triglyceride Levels: Change From Baseline
Twelve months
|
7.9 mg/dl
Standard Deviation 76
|
-57.4 mg/dl
Standard Deviation 259
|
-1.1 mg/dl
Standard Deviation 114
|
|
Triglyceride Levels: Change From Baseline
Six months
|
12.5 mg/dl
Standard Deviation 80
|
-56.0 mg/dl
Standard Deviation 253
|
-21.3 mg/dl
Standard Deviation 81
|
|
Triglyceride Levels: Change From Baseline
Twenty-four months
|
-8.6 mg/dl
Standard Deviation 71
|
-31.8 mg/dl
Standard Deviation 228
|
-4.1 mg/dl
Standard Deviation 86
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=51 Participants
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.
|
In Person Group (IP)
n=61 Participants
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.
|
Telephone Conference Call Group (TCC)
n=58 Participants
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.
|
|---|---|---|---|
|
Diet Self-efficacy: Change From Baseline
Twenty-four months
|
-0.2 score on a scale
Standard Deviation 0.8
|
0.3 score on a scale
Standard Deviation 0.7
|
-0.1 score on a scale
Standard Deviation 0.8
|
|
Diet Self-efficacy: Change From Baseline
Thirty-six months
|
-0.1 score on a scale
Standard Deviation 0.9
|
-0.1 score on a scale
Standard Deviation 0.9
|
-0.4 score on a scale
Standard Deviation 0.8
|
|
Diet Self-efficacy: Change From Baseline
Six months
|
-0.2 score on a scale
Standard Deviation 0.7
|
0.3 score on a scale
Standard Deviation 0.7
|
0.1 score on a scale
Standard Deviation 0.6
|
|
Diet Self-efficacy: Change From Baseline
Twelve months
|
-0.3 score on a scale
Standard Deviation 0.8
|
0.2 score on a scale
Standard Deviation 0.8
|
-0.1 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=53 Participants
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.
|
In Person Group (IP)
n=62 Participants
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.
|
Telephone Conference Call Group (TCC)
n=59 Participants
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.
|
|---|---|---|---|
|
Fat-related Diet Behavior: Change From Baseline.
Six months
|
-0.1 score on a scale
Standard Deviation 0.4
|
-0.4 score on a scale
Standard Deviation 0.5
|
-0.3 score on a scale
Standard Deviation 0.5
|
|
Fat-related Diet Behavior: Change From Baseline.
Twelve months
|
-0.2 score on a scale
Standard Deviation 0.4
|
-0.4 score on a scale
Standard Deviation 0.5
|
-0.3 score on a scale
Standard Deviation 0.5
|
|
Fat-related Diet Behavior: Change From Baseline.
Twenty-four months
|
-0.2 score on a scale
Standard Deviation 0.4
|
-0.4 score on a scale
Standard Deviation 0.4
|
-0.4 score on a scale
Standard Deviation 0.5
|
|
Fat-related Diet Behavior: Change From Baseline.
Thirty-six months
|
-0.3 score on a scale
Standard Deviation 0.5
|
-0.3 score on a scale
Standard Deviation 0.4
|
-0.3 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=54 Participants
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.
|
In Person Group (IP)
n=62 Participants
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.
|
Telephone Conference Call Group (TCC)
n=59 Participants
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.
|
|---|---|---|---|
|
Dietary Restraint: Change From Baseline
Six months
|
0.4 score on a scale
Standard Deviation 0.7
|
0.6 score on a scale
Standard Deviation 0.6
|
0.6 score on a scale
Standard Deviation 0.7
|
|
Dietary Restraint: Change From Baseline
Twelve months
|
0.5 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 0.6
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Dietary Restraint: Change From Baseline
Twenty-four months
|
0.3 score on a scale
Standard Deviation 0.7
|
0.7 score on a scale
Standard Deviation 0.7
|
0.6 score on a scale
Standard Deviation 0.6
|
|
Dietary Restraint: Change From Baseline
Thirty six months
|
0.4 score on a scale
Standard Deviation 0.4
|
0.7 score on a scale
Standard Deviation 0.7
|
0.4 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=54 Participants
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.
|
In Person Group (IP)
n=62 Participants
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.
|
Telephone Conference Call Group (TCC)
n=59 Participants
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.
|
|---|---|---|---|
|
Diabetes Distress: Change From Baseline
Six months
|
-7.0 score on a scale
Standard Deviation 17.6
|
-12.4 score on a scale
Standard Deviation 20.3
|
-14.1 score on a scale
Standard Deviation 19.4
|
|
Diabetes Distress: Change From Baseline
Twelve months
|
-5.8 score on a scale
Standard Deviation 18
|
-14.4 score on a scale
Standard Deviation 15
|
-15.1 score on a scale
Standard Deviation 21.9
|
|
Diabetes Distress: Change From Baseline
Twenty-four months
|
-9.2 score on a scale
Standard Deviation 22.8
|
-13.0 score on a scale
Standard Deviation 15.3
|
-16.3 score on a scale
Standard Deviation 20
|
|
Diabetes Distress: Change From Baseline
Thirty-six months
|
-13.4 score on a scale
Standard Deviation 22.9
|
-14.1 score on a scale
Standard Deviation 17.8
|
-14.3 score on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=53 Participants
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.
|
In Person Group (IP)
n=62 Participants
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.
|
Telephone Conference Call Group (TCC)
n=57 Participants
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.
|
|---|---|---|---|
|
Depression Score: Change From Baseline.
Six months
|
-0.6 score on a scale
Standard Deviation 4.5
|
-1.0 score on a scale
Standard Deviation 3.3
|
-0.7 score on a scale
Standard Deviation 3.1
|
|
Depression Score: Change From Baseline.
Twelve months
|
-0.9 score on a scale
Standard Deviation 4.1
|
-1.2 score on a scale
Standard Deviation 2.8
|
-0.4 score on a scale
Standard Deviation 3.7
|
|
Depression Score: Change From Baseline.
Twenty-four months
|
-1.0 score on a scale
Standard Deviation 4.3
|
-0.8 score on a scale
Standard Deviation 3.2
|
-0.1 score on a scale
Standard Deviation 3.1
|
|
Depression Score: Change From Baseline.
Thirty-six months
|
-0.9 score on a scale
Standard Deviation 5.2
|
-0.7 score on a scale
Standard Deviation 3.7
|
0.2 score on a scale
Standard Deviation 4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsTotal 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.
Outcome measures
| Measure |
Medical Nutrition Therapy (MNT)
n=64 Participants
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.
|
In Person Group (IP)
n=69 Participants
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.
|
Telephone Conference Call Group (TCC)
n=70 Participants
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.
|
|---|---|---|---|
|
Health Economics
|
591 US Dollar
Interval 162.0 to 1005.0
|
1390 US Dollar
Interval 962.0 to 1772.0
|
1814 US Dollar
Interval 1384.0 to 2266.0
|
Adverse Events
Medical Nutrition Therapy (MNT)
Serious events: 18 serious events
Other events: 0 other events
Deaths: 1 deaths
In Person Group (IP)
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone Conference Call Group (TCC)
Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Medical Nutrition Therapy (MNT)
n=66 participants at risk
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.
|
In Person Group (IP)
n=70 participants at risk
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.
|
Telephone Conference Call Group (TCC)
n=72 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Hospital admission
|
27.3%
18/66 • Number of events 25 • 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.
|
22.9%
16/70 • Number of events 17 • 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.
|
16.7%
12/72 • Number of events 16 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place