Trial Outcomes & Findings for Translating a Heart Disease Lifestyle Intervention Into the Community (NCT NCT01647438)

Results Overview

Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

baseline and 6-months

Results posted on

2015-11-02

Participant Flow

Community outreach

Participant milestones

Participant milestones
Measure	Primary Care Referral and Print Health Education Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.	Lifestyle Intervention Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
Overall Study STARTED	32	31
Overall Study COMPLETED	32	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Translating a Heart Disease Lifestyle Intervention Into the Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Care Referral and Print Health Education n=32 Participants Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.	Lifestyle Intervention n=31 Participants Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.	Total n=63 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	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 7 • n=5 Participants	50 years STANDARD_DEVIATION 8 • n=7 Participants	50 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6-months

Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.

Outcome measures

Outcome measures
Measure	Primary Care Referral and Print Health Education n=32 Participants Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.	Lifestyle Intervention n=31 Participants Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
Change in Physical Activity (Minutes/Week)	4 min/week Standard Error 14	10 min/week Standard Error 15

PRIMARY outcome

Timeframe: baseline and 6-months

Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months

Outcome measures

Outcome measures
Measure	Primary Care Referral and Print Health Education n=32 Participants Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.	Lifestyle Intervention n=31 Participants Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake	0.58 percentage of kilocalories Standard Error 0.51	0.37 percentage of kilocalories Standard Error 0.52

Adverse Events

Primary Care Referral and Print Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Intervention

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. Namratha Kandula, Principal Investigator

Northwestern University

Phone: 312-503-6470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place