Trial Outcomes & Findings for Peer-Led Diet and Exercise Intervention (NCT NCT04994938)

NCT ID: NCT04994938

Last Updated: 2026-02-17

Results Overview

Cardiovascular endurance will be assessed with the distance covered during a six-minute walk test. The distance covered from baseline will be compared to post 12-week intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 12-weeks
• Results posted on: 2026-02-17

Participant Flow

Both Peer Leaders and Participants were recruited and consented for this study. However, data was only collected for the 14 participants (who were studied), data was not collected for peer leaders.

Participant milestones

Measure	Peer Led Diet and Exercise Intervention - All Study Participants participation in two-times per week diet and exercise peer led interventions.
Overall Study STARTED	30
Overall Study Peer Leaders	9
Overall Study Index Participants	14
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peer-Led Diet and Exercise Intervention

Baseline characteristics by cohort

Measure	Peer Led Diet and Exercise Intervention n=14 Participants participation in two-times per week diet and exercise peer led interventions.
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=25 Participants
Age, Categorical >=65 years	14 Participants n=25 Participants
Age, Continuous	76.3 years STANDARD_DEVIATION 5.7 • n=25 Participants
Sex: Female, Male Female	1 Participants n=25 Participants
Sex: Female, Male Male	13 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	7 Participants n=25 Participants
Race (NIH/OMB) White	7 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Region of Enrollment United States	14 Participants n=25 Participants

PRIMARY outcome

Timeframe: 12-weeks

Population: Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders

Cardiovascular endurance will be assessed with the distance covered during a six-minute walk test. The distance covered from baseline will be compared to post 12-week intervention.

Outcome measures

Measure	Peer Led Diet and Exercise Intervention n=14 Participants participation in two-times per week diet and exercise peer led interventions.
Change in Cardiovascular Endurance	20 yards Standard Deviation 5

PRIMARY outcome

Timeframe: 12-weeks

Population: Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders

Food records will be gathered and analyzed using the automated self-administered recall system (ASA24) to evaluate diet quality. Results from baseline will be compared to those after 12 weeks of intervention. The Healthy Eating Index (HEI) is a summary score describing dietary quality on a 0-100 scale; higher scores indicate better diet quality.

Outcome measures

Measure	Peer Led Diet and Exercise Intervention n=14 Participants participation in two-times per week diet and exercise peer led interventions.
Change in Diet Quality as Measured by the HEI Score	1.9 score on a scale of 100 Standard Deviation 2.4

SECONDARY outcome

Timeframe: 12-weeks

Population: Outcomes were collected only for the 14 participants, therefore, the results of this single are pilot study are reported and based on the 14 study participants and do not include Peer Leaders

The number of time and individuals can rise from a chair-without using their arms during a 30-second time period will be recorded and used as a measure of mobility. Results from baseline will be compared to those after 12-weeks of intervention.

Outcome measures

Measure	Peer Led Diet and Exercise Intervention n=14 Participants participation in two-times per week diet and exercise peer led interventions.
Change in Mobility as Measured by the 30 Second Chair Stand Test	1.4 stands Standard Deviation 0.7

Adverse Events

Peer Leader

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Peer Led Diet and Exercise Intervention

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Peer Leader n=9 participants at risk Peer leaders trained to lead the interventions two times per week	Peer Led Diet and Exercise Intervention n=14 participants at risk participation in two-times per week diet and exercise peer led interventions.
Cardiac disorders Hospitalization	0.00% 0/9 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.	7.1% 1/14 • Number of events 1 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.
Cardiac disorders Vertigo	0.00% 0/9 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.	7.1% 1/14 • Number of events 1 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.

Other adverse events

Measure	Peer Leader n=9 participants at risk Peer leaders trained to lead the interventions two times per week	Peer Led Diet and Exercise Intervention n=14 participants at risk participation in two-times per week diet and exercise peer led interventions.
Infections and infestations Positive COVID test	11.1% 1/9 • Number of events 1 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.	0.00% 0/14 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.
Cardiac disorders SOB and Chest Pain	11.1% 1/9 • Number of events 1 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.	0.00% 0/14 • Adverse events were collected during participant's entire duration of study participation, which was 12 weeks. The ClinicalTrials.gov definition of adverse events and serious adverse events was used to collect adverse event information.

Additional Information

Dr. Odessa Addison

Baltimore VAMC

Phone: 410-605-7000

Email: Odessa.Addison@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place