An interventional study of Diabetes Prevention Program-Remote (DPP-R) and Diabetes Prevention Program-Facebook (DPP-FB) in PreDiabetes, Weight Loss and Lifestyle Risk Reduction, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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.
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 31 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Diabetes Prevention Program-Remote (DPP-R)
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.
Behavioral: Diabetes Prevention Program-Facebook (DPP-FB)
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Zoom.
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook.
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
Participant Retention
Retention will be defined as attendance at 6 mo. outcome testing.
Time frame: 6 months
Average Program Attendance
Program attendance will be defined as average percentage of sessions attended by group.
Time frame: 6 months
| Milestone | DPP-R | DPP-FB |
|---|---|---|
| Started | 16 | 15 |
| Completed | 14 | 13 |
| Not completed | 2 | 2 |
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.
| kilograms | DPP-R | DPP-FB |
|---|---|---|
| Change in Body Weight From 0-6 Months | -6.0 ± 8.0 | -1.7 ± 3.3 |
Retention will be defined as attendance at 6 mo. outcome testing.
| Participants | DPP-R | DPP-FB |
|---|---|---|
| Participant Retention | 14 | 13 |
Program attendance will be defined as average percentage of sessions attended by group.
| Average percentage of sessions attended | DPP-R | DPP-FB |
|---|---|---|
| Average Program Attendance | 69 ± 23.5 | 83 ± 26.6 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DPP-R | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| DPP-FB | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | DPP-R | DPP-FB | Total |
|---|---|---|---|
| Mean | 56.4 ± 11.1 | 53.8 ± 14.7 | 55.1 ± 12.8 |
| Sex: Female, Male(Participants) | DPP-R | DPP-FB | Total |
|---|---|---|---|
| Female | 12 | 13 | 25 |
| Male | 4 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | DPP-R | DPP-FB | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 13 | 13 | 26 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | DPP-R | DPP-FB | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 14 | 14 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | DPP-R | DPP-FB | Total |
|---|---|---|---|
| United States | 16 | 15 | 31 |
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University of Kansas Medical Center