Lifestyle Risk Reduction, PreDiabetes, Weight Loss
Conditions
Brief summary
The purpose of this pilot trial is to compare feasibility and effectiveness of remote delivery (social media or video conferencing) of the National Diabetes Prevention Program (N-DPP) to adults in rural communities. The research team will train a Kansas State Research and Extension staff to deliver the video conferencing arm while a research team member will lead the social media arm.
Detailed description
This pilot trial will compare the feasibility and effectiveness of DPP delivered through Facebook (DPP-FB) or group format delivered remotely by Zoom (DPP-R) in adults in rural communities. Both interventions will recruit through the Corporative Extension Service (CES), which serves as the community outreach arm of all land grant universities through over 2,900 offices across the U.S. The Kansas State Research and Extension (KSRE) (Kansas version of CES), is well positioned, but underutilized for the delivery of DPP in rural areas. Delivery of DPP by a well-recognized entity, such as the KSRE, may improve the probability of dissemination and long-term program sustainability. Two CES offices serving rural counties in Kansas will be randomized (1:1) to the DPP-FB or DPP-R arms. Our research team will train one professional staff from KSRE (with backgrounds in nutrition programming and family consumer science) to deliver the DPP-R intervention. A research team member will deliver the DPP-FB intervention. This project will address the following aims: Primary aim: Compare weight and MVPA between DPP-FB and DPP-R across 6 mos. The investigators expect greater weight loss and MVPA in the DPP-R arm compared with the DPP-FB arm. Secondary aim: Compare the feasibility of DPP-FB and DPP-R across 6 mos. based on participant retention and program attendance. The investigators expect greater participant retention and program attendance in the DPP-R arm compared with the DPP-FB arm.
Interventions
BEHAVIORALDiabetes Prevention Program-Remote (DPP-R)
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Zoom.
BEHAVIORALDiabetes Prevention Program-Facebook (DPP-FB)
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook.
Sponsors
Kansas State University
National Institute of General Medical Sciences (NIGMS)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Two rural KSRE local units will be randomized in a 1:1 ratio to either DPP-FB or DPP-R.
Intervention model description
The proposed 2-arm trial will compare the feasibility and effectiveness of Facebook or remote-delivery of the DPP in rural adults with prediabetes both delivered through the KSRE. The CES is a non-formal educational program, implemented in the U.S. through each state's designated land grant university, to help people use research-based knowledge to improve their lives. The KSRE maintains local units which are comprised of single counties or multi-county districts. Two KSRE local units serving rural counties will be identified by our partners at KSRE and randomized to the Facebook or remote delivery arms. Members of the KUMC research team will recruit and consent participants and will train KSRE personnel to deliver the 30 core-sessions of the DPP protocol over 12 mos. Outcomes will be assessed by the research team at the local CES offices at baseline, 3 mos. 6 mos. and 12 mos.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Prediabetes as defined as A1C = 5.7-6.4%, fasting glucose = 100-125 mg/dl, (confirmed from physician/medical record in the previous year), history of gestation diabetes mellitus OR a positive result based on the CDC- DPP screener 2. Age ≥18 yrs. 3. Willing to commit to participate on a weekly basis for the 6 month intervention 4. Living in the county of a rural KSRE local unit. Rural counties will be defined using the American Community Survey definition which categorizes a county as rural if the population is \< 65,000 5. Internet access and capability to use Zoom 6. Clearance from primary care physician
Exclusion criteria
1. Diagnosis of Type 2 diabetes 2. Unable to participate in physical activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight From 0-6 Months | Baseline - 6 months | Anthropometric measurements: Body weight will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600, Saukville, WI). All participants will be weighed between the hours of 6 and 11 am following a 12 hr. fast in a standard hospital gown. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention | 6 months | Retention will be defined as attendance at 6 mo. outcome testing. |
| Average Program Attendance | 6 months | Program attendance will be defined as average percentage of sessions attended by group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DPP-R Weekly 60 min. group meetings, lead by trained KSRE staff, (12-15 participants) will be held by Zoom over 6 months followed by monthly 60 min. group meetings for the later 6 months. Approximately 5 min prior to the meeting time (typically early evening) participants will receive call in information to join the group meeting by video conferencing or phone.
Diabetes Prevention Program-Remote (DPP-R): The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Zoom. | 16 |
| DPP-FB Participants will be asked to join a secret, research team moderated, Facebook® group, which is only accessible by group members. The health educator will post the module, de-identified participant self-monitoring data, and comment on individuals posts weekly. Brief discussion prompts are designed to reinforce the primary objectives of each module and to facilitate inter-participant discussion around these topics. Responses will be monitored and tracked. This is analogous to attendance in the Zoom® group.
Diabetes Prevention Program-Facebook (DPP-FB): The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | DPP-R | Total | DPP-FB |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 11.1 | 55.1 years STANDARD_DEVIATION 12.8 | 53.8 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 26 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 16 participants | 31 participants | 15 participants |
| Sex: Female, Male Female | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
Change in Body Weight From 0-6 Months
Anthropometric measurements: Body weight will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600, Saukville, WI). All participants will be weighed between the hours of 6 and 11 am following a 12 hr. fast in a standard hospital gown.
Time frame: Baseline - 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DPP-R | Change in Body Weight From 0-6 Months | -6.0 kilograms | Standard Deviation 8 |
| DPP-FB | Change in Body Weight From 0-6 Months | -1.7 kilograms | Standard Deviation 3.3 |
Secondary
Average Program Attendance
Program attendance will be defined as average percentage of sessions attended by group.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DPP-R | Average Program Attendance | 69 Average percentage of sessions attended | Standard Deviation 23.5 |
| DPP-FB | Average Program Attendance | 83 Average percentage of sessions attended | Standard Deviation 26.6 |
Secondary
Participant Retention
Retention will be defined as attendance at 6 mo. outcome testing.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DPP-R | Participant Retention | 14 Participants |
| DPP-FB | Participant Retention | 13 Participants |