Trial Outcomes & Findings for Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial (NCT NCT06016725)
NCT ID: NCT06016725
Last Updated: 2026-01-02
Results Overview
Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
end-of-intervention, at 12 weeks
Results posted on
2026-01-02
Participant Flow
Participant milestones
| Measure |
Arm 1 (Nutritional Counseling, Resistance Training)
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (Educational Materials)
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial
Baseline characteristics by cohort
| Measure |
Arm 1 (Nutritional Counseling, Resistance Training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (Educational Materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=228 Participants
|
37 Participants
n=115 Participants
|
75 Participants
n=343 Participants
|
|
Age, Continuous
|
69 years
n=228 Participants
|
70 years
n=115 Participants
|
70 years
n=343 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=228 Participants
|
26 Participants
n=115 Participants
|
52 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=228 Participants
|
11 Participants
n=115 Participants
|
23 Participants
n=343 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=228 Participants
|
4 Participants
n=115 Participants
|
8 Participants
n=343 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=228 Participants
|
33 Participants
n=115 Participants
|
63 Participants
n=343 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=343 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=228 Participants
|
37 participants
n=115 Participants
|
75 participants
n=343 Participants
|
|
Short Physical Performance Battery
|
9.2 units on a scale
n=228 Participants
|
9.1 units on a scale
n=115 Participants
|
9.1 units on a scale
n=343 Participants
|
|
Grip strength
|
27.3 kg
STANDARD_DEVIATION 4.8 • n=228 Participants
|
26.8 kg
STANDARD_DEVIATION 4.3 • n=115 Participants
|
27.0 kg
STANDARD_DEVIATION 4.5 • n=343 Participants
|
|
Diet History Questionnaire III
|
66.9 units on a scale
n=228 Participants
|
65.8 units on a scale
n=115 Participants
|
66.3 units on a scale
n=343 Participants
|
|
Godin leisure time exercise
|
43 units on a scale
STANDARD_DEVIATION 9.8 • n=228 Participants
|
42 units on a scale
STANDARD_DEVIATION 9.2 • n=115 Participants
|
43 units on a scale
STANDARD_DEVIATION 9.6 • n=343 Participants
|
|
RAND-36
|
64.2 units on a scale
STANDARD_DEVIATION 19.2 • n=228 Participants
|
63.0 units on a scale
STANDARD_DEVIATION 21.3 • n=115 Participants
|
63.6 units on a scale
STANDARD_DEVIATION 20.1 • n=343 Participants
|
|
Self-efficacy for diet and exercise
|
7.6 units on a scale
STANDARD_DEVIATION 2.1 • n=228 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 2.3 • n=115 Participants
|
8.08 units on a scale
STANDARD_DEVIATION 2.2 • n=343 Participants
|
|
Self-regulation for diet and exercise
|
35.7 units on a scale
STANDARD_DEVIATION 9.8 • n=228 Participants
|
35.6 units on a scale
STANDARD_DEVIATION 10.3 • n=115 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 9.9 • n=343 Participants
|
|
eHealth Literacy Scale
|
33.4 units on a scale
STANDARD_DEVIATION 5.4 • n=228 Participants
|
32.3 units on a scale
STANDARD_DEVIATION 6.9 • n=115 Participants
|
32.8 units on a scale
STANDARD_DEVIATION 6.2 • n=343 Participants
|
PRIMARY outcome
Timeframe: end-of-intervention, at 12 weeksMeasured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Physical Function at End-of-intervention
|
9.2 score on a scale
Standard Deviation 2.2
|
9.1 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksPercentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
|
5 score on a scale
Interval 1.0 to 5.0
|
5 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: assessed during the 12 month recruitment periodPopulation: The number of participants analyzed represents all potential older cancer survivors (OCS) contacted and assessed for eligibility for participation in the study.
Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=324 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Study Accrual Rate
|
23.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: End-of-study, up to 3 monthscalculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Study Retention Rate
|
30 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksPopulation: Percentage of Participants who Attended \>= 80% of the Intervention Sessions
Participants were determined to be adherent if they attend \>= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Study Adherence Rate
|
97 percentage of participants
|
95 percentage of participants
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksHandgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Grip Strength
|
28.6 kgs
Standard Deviation 5.2
|
28.3 kgs
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksDietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Dietary Quality
|
69.3 score on a scale
Interval 63.0 to 76.0
|
68.1 score on a scale
Interval 61.0 to 75.0
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksSelf-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted "yes" to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Percentage of Participants Who Completed Resistance Exercises
|
97 percentage of participants
|
65 percentage of participants
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksRAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Health-related Quality of Life (HRQoL)
|
53.8 score on a scale
Standard Error 18.9
|
60.1 score on a scale
Standard Error 19.1
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksSelf-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Self-efficacy
|
9.47 score on a scale
Standard Deviation 2.1
|
8.97 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksThe 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Technology Competency
|
33.9 score on a scale
Interval 27.0 to 40.0
|
33.2 score on a scale
Interval 26.0 to 40.0
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksAt end-of-intervention, participant's body weight was assessed in kilograms.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Anthropometry Body Weight in Kilograms
|
28 kg
Interval 26.0 to 32.0
|
29 kg
Interval 24.0 to 33.0
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksAt end-of-intervention, participants' height was assessed using height in centimeters.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Anthropometry Height in Inches
|
165.2 cm
Standard Deviation 5.2
|
166.1 cm
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: end-of-intervention, at 12 weeksAt end-of-intervention, participants' waist circumference was assessed in centimeters.
Outcome measures
| Measure |
Arm 1 (nutritional counseling, resistance training)
n=38 Participants
Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
Exercise Intervention: Participate in online resistance training sessions
Informational Intervention: Given educational materials
Nutritional Assessment: Participate in online nutritional counseling
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm 2 (educational materials)
n=37 Participants
Patients receive educational materials at baseline.
Informational Intervention: Given educational materials
Physical Performance Testing: Ancillary studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Anthropometry Measuring Waist Circumference in Centimeters
|
100 cm
Interval 90.0 to 110.0
|
101 cm
Interval 89.0 to 113.0
|
Adverse Events
Arm 1 (Nutritional Counseling, Resistance Training)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 (Educational Materials)
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. Jessica Krok-Schoen, Associate Professor
School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University
Phone: 8133686470
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place