PreDiabetes, Type 2 Diabetes
Conditions
Keywords
prevention, Type 2 Diabetes, prediabetes, group intervention
Brief summary
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.
Interventions
BEHAVIORALProject Health
Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle.
We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator and follow-up assessors will be blinded to condition
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 18 and 65 2. Overweight (BMI between 25 and 40 kg/m2) 3. Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Exclusion criteria
1. Not between the ages of 18 and 65 2. Not overweight (BMI between 25 and 40 kg/m2) 3. Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) - Post-Test | post-test (immediately after completion of 6 week intervention) | BMI will be assessed at post-test to see which intervention produced greater reductions in BMI |
| Body Mass Index (BMI) - 3-Month Follow-Up | 3-month follow-up | BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI |
| HbA1c at 3-month Follow-up | 3-month follow-up | Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status |
| Fasting Plasma Glucose | 3-month follow-up | Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status |
| Percent Body Fat - Post-Test | post-test (immediately after completion of 6 week intervention) | — |
| Percent Body Fat - 3-Month Follow-Up | 3-month follow-up | — |
| Percent Lean Body Mass - Post-Test | post-test (immediately after completion of 6 week intervention) | — |
| Percent Lean Body Mass - 3-Month Follow-Up | 3-month follow-up | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle.
Project Health: Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle. | 30 |
| Control We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan
Educational Video Control: We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan | 32 |
| Total | 62 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 32 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 29 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 19 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 11 Participants | 8 Participants | 19 Participants |
| Region of Enrollment United States | 30 participants | 32 participants | 62 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Body Mass Index (BMI) - 3-Month Follow-Up
BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Body Mass Index (BMI) - 3-Month Follow-Up | 30.3 kg/m2 | Standard Deviation 6.5 |
| Control | Body Mass Index (BMI) - 3-Month Follow-Up | 28.7 kg/m2 | Standard Deviation 5.5 |
Primary
Body Mass Index (BMI) - Post-Test
BMI will be assessed at post-test to see which intervention produced greater reductions in BMI
Time frame: post-test (immediately after completion of 6 week intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Body Mass Index (BMI) - Post-Test | 30.3 kg/m2 | Standard Deviation 6.6 |
| Control | Body Mass Index (BMI) - Post-Test | 28.8 kg/m2 | Standard Deviation 5.3 |
Primary
Fasting Plasma Glucose
Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Fasting Plasma Glucose | 107 mg/dL | Standard Deviation 12 |
| Control | Fasting Plasma Glucose | 108 mg/dL | Standard Deviation 13 |
Primary
HbA1c at 3-month Follow-up
Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | HbA1c at 3-month Follow-up | 5.8 percent | Standard Deviation 0.4 |
| Control | HbA1c at 3-month Follow-up | 6 percent | Standard Deviation 0.4 |
Primary
Percent Body Fat - 3-Month Follow-Up
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent Body Fat - 3-Month Follow-Up | 38.3 percent body fat | Standard Deviation 9.8 |
| Control | Percent Body Fat - 3-Month Follow-Up | 37.8 percent body fat | Standard Deviation 8 |
Primary
Percent Body Fat - Post-Test
Time frame: post-test (immediately after completion of 6 week intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent Body Fat - Post-Test | 39.2 percent body fat | Standard Deviation 9.5 |
| Control | Percent Body Fat - Post-Test | 38.4 percent body fat | Standard Deviation 7.8 |
Primary
Percent Lean Body Mass - 3-Month Follow-Up
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent Lean Body Mass - 3-Month Follow-Up | 61.6 percent lean mass | Standard Deviation 9.7 |
| Control | Percent Lean Body Mass - 3-Month Follow-Up | 62.2 percent lean mass | Standard Deviation 7.9 |
Primary
Percent Lean Body Mass - Post-Test
Time frame: post-test (immediately after completion of 6 week intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent Lean Body Mass - Post-Test | 60.9 percent lean mass | Standard Deviation 9.6 |
| Control | Percent Lean Body Mass - Post-Test | 61.6 percent lean mass | Standard Deviation 7.8 |