Trial Outcomes & Findings for Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio (NCT NCT05040152)

Results Overview

Will be defined as the number of enrolled participants who complete the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Up to 15 weeks

Results posted on

2025-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Telephone-based Intervention) Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies
Overall Study STARTED	27	13
Overall Study COMPLETED	22	11
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Telephone-based Intervention) Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies
Overall Study Withdrawal by Subject	5	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 15 weeks

Will be defined as the number of enrolled participants who complete the study.

Outcome measures

Outcome measures
Measure	Arm I (Telephone-based Intervention) n=27 Participants Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) n=13 Participants Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies
Feasibility of a 15-week Telephone-based Weight Loss Intervention	22 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 15 weeks

Population: The number of participants analyzed is the number that the 15 week intervention and the 15 week follow-up

Changes in body weight (KG)will be measured by a weight scale

Outcome measures

Outcome measures
Measure	Arm I (Telephone-based Intervention) n=22 Participants Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) n=11 Participants Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies
Changes in Body Weight (KG)	-4.93 kg Standard Error 1.12	-2.09 kg Standard Error 1.58

SECONDARY outcome

Timeframe: Up to 15 weeks

Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Outcome measures

Outcome measures
Measure	Arm I (Telephone-based Intervention) n=22 Participants Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) n=11 Participants Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies
Changes in Body Fat Mass	0.23 lb Standard Error 3.46	0.11 lb Standard Error 2.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be obtained by fasting capillary blood sampling from fingerstick and analyzed using Cholestech LDX

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Self-reported using Leisure-Time Exercise Questionnaires118. Objectively measured physical activity will be recorded using the LIFECORDER Plus Accelerometer for 7 days in the 1st and 15th week

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 15 weeks

Self-reported using the National Institutes of Health Daily Food List

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Telephone-based Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Education Brochures)

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

Xiaochen Zhang

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Telephone-based Intervention) n=27 Participants Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention	Arm II (Education Brochures) n=13 Participants Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	13 Participants n=7 Participants	40 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	13 participants n=7 Participants	40 participants n=5 Participants