Diabetes
Conditions
Keywords
prevention, weight loss, community, personalized, telephone, resources, lifestyle intervention, racial ethnic minorities / African American, faith based, obesity, non-responders, adults, cancer
Brief summary
This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted. This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.
Interventions
BEHAVIORALDPP-GLB Standard
The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
BEHAVIORALDPP-GLB Enhanced
The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
Sponsors
Lovoria Williams
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* self-described as Black * non-diabetic * body mass index (BMI) equal to or greater than 25 * CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes * live within driving distance of participating church/site
Exclusion criteria
* diagnosed Type 1 or 2 diabetes * pregnant or planning to become pregnant during study period * contraindications to moderate physical activity * serious medical condition that contradicts weight loss * not Black or African American
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight at 12 Weeks | 12 weeks (at baseline and12 weeks) | Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks. |
| Change in Weight at 6 Months | 6 months (at baseline and 6 months) | Weight will be measured in pounds using a cellular scale at baseline and at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure at 12 Weeks | 12 weeks (at baseline and 12 weeks) | Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks. |
| Change in Blood Pressure at 6 Months | 6 months (at baseline and 6 months) | Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months. |
| Change in Physical Activity at 12 Weeks | 12 weeks (at baseline and 12 weeks) | Change in Physical Activity will be measured at baseline and 12-week using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity. |
| Change in Physical Activity at 6 Months | 6 months (at baseline and 6 months) | Change in Physical Activity will be measured at baseline and 6-month using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity. |
| Change in Dietary Intake at 12 Weeks | 12 weeks (at baseline and 12 weeks) | Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100. |
| Change in Dietary Intake at 6 Months | 6 months (at baseline, 12 weeks, 6 months) | Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100. |
| Cost Analysis | 6 months | Investigator-developed instrument. At 6 months, conduct a cost-effectiveness analysis to evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm. The generated final output is the cost per participant in dollars. |
| Impact of Weight on Quality of Life | 6 months | Quality of life will be measured using Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). This is a 31-item self-report scale. Scores range from 0-100; higher scores indicate greater quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLovoria Williams
University of Kentucky
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 12.2 |
| College or graduate degree | 106 Participants |
| Income > $50,000 annually | 95 Participants |
| Married/partnered | 86 Participants |
| Private Insurance | 120 Participants |
| Race/Ethnicity, Customized African American / Black | 403 Participants |
| Region of Enrollment United States | 403 participants |
| Sex: Female, Male Female | 163 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 200 |
| other Total, other adverse events | 0 / 203 | 0 / 200 |
| serious Total, serious adverse events | 0 / 203 | 0 / 200 |
Outcome results
None listed