Trial Outcomes & Findings for The National Diabetes Prevention Program in Rural Communities (NCT NCT05387434)

Last Updated: 2023-12-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Baseline - 6 months

Results posted on

2023-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	16	15
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The National Diabetes Prevention Program in Rural Communities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DPP-R n=16 Participants 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.	DPP-FB n=15 Participants 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.	Total n=31 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 11.1 • n=5 Participants	53.8 years STANDARD_DEVIATION 14.7 • n=7 Participants	55.1 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - 6 months

Outcome measures

Outcome measures
Measure	DPP-R n=14 Participants 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.	DPP-FB n=13 Participants 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.
Change in Body Weight From 0-6 Months	-6.0 kilograms Standard Deviation 8.0	-1.7 kilograms Standard Deviation 3.3

SECONDARY outcome

Timeframe: 6 months

Retention will be defined as attendance at 6 mo. outcome testing.

Outcome measures

Outcome measures
Measure	DPP-R n=16 Participants 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.	DPP-FB n=15 Participants 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.
Participant Retention	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 6 months

Program attendance will be defined as average percentage of sessions attended by group.

Outcome measures

Outcome measures
Measure	DPP-R n=16 Participants 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.	DPP-FB n=15 Participants 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.
Average Program Attendance	69 Average percentage of sessions attended Standard Deviation 23.5	83 Average percentage of sessions attended Standard Deviation 26.6

Adverse Events

DPP-R

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DPP-FB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anna Gorczyca

University of Kansas Medical Center

Phone: 913-588-9077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place