Effects of a community-based heart-healthy lifestyle promoting program
| ISRCTN | ISRCTN83643383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83643383 |
| Secondary identifying numbers | NRF-2019R1A2C1004116 |
- Submission date
- 26/08/2022
- Registration date
- 04/10/2022
- Last edited
- 31/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
There is little information on the effects of offline and online behavioral strategies on heart-healthy behaviors in cardiovascular prevention, compared to an online-only strategy. In this context, we designed an Heart-Healthy Lifestyle Promoting Program (i.e., HeartHELP program) using a hybrid behavioral strategy. The hybrid behavioral strategy comprises a combined intervention of both mobile-app and motivational interviewing. The mobile-app use is an intervention mode as an online strategy, while motivational interviewing is an intervention mode as an offline strategy in the present study. We have two aims: First, a hybrid-intervention group would have greater improvements in the indices of heart-healthy behaviors than a control group. Second, a hybrid-intervention group would have greater improvements in the indices of heart-healthy behaviors than a mobile-app group.
Who can participate?
Study participants are 75 adults who are community-dwelling individuals at risk for cardiovascular disease, having at least one component of metabolic syndrome.
What does the study involve?
The study participants will be randomly assigned to control, mobile-app, or hybrid groups. The HeartHELP program is a 12 week intervention comprising of both mobile-app use and motivational interviewing based on a hybrid behavioral strategy. The hybrid group will receive the 12-week HeartHELP program as online and offline strategies, the mobile-app group will receive an intervention of mobile-app use. as online strategies. The mobile-app was developed by the principal investigator and consists of technologies for information, self-monitoring and feedback. The control group will receive paper-based information about cardiovascular prevention.
What are the possible benefits and risks of participating?
Participants of control, mobile-app, and hybrid groups may have knowledge and skills for cardiovascular prevention and promotion through participating in the pre-test of the self-reported questionnaires, anthropometric measures, and blood works and receiving heart-healthy information. Moreover, each group will receive cash incentives according to their participation levels. Participants may have some physical and psychological discomforts through spending time responding to survey questionnaires, physical measures, and blood work. More specifically, blood works are an invasive procedure with physical pain and problems (i.e., swelling or inflammation). In this case, the blood work will be conducted by skilled nurses who had more than three-year clinical experience. For the measurement of waist circumference, we will protect privacy by providing private space and a skilled-measurement procedure.
Where is the study run from?
College of Nursing, Korea University
When is the study starting and how long is it expected to run for?
August 2022 to August 2023
Who is funding the study?
National Research Foundation of Korea (NRF) grant from the Korean Government (No. NRF-2019R1A2C1004116).
Who is the main contact?
Jina Choo, PhD, DrPH, RN, jinachoo@korea.ac.kr
Contact information
Principal Investigator
College of Nursing, Korea University
145 Anam-ro
Seoungbuk-gu
Seoul
02841
Korea, South
 ORCID ID |
0000-0001-9271-3689 |
|---|---|
| Phone | +82-2-3290-4925 |
| jinachoo@korea.ac.kr |
Study information
| Study design | Randomized controlled trial with three groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effects of a community-based Heart-HEalthy Lifestyle Promoting program: using a hybrid behavioral strategy |
| Study acronym | HeartHELP study |
| Study objectives | 1. A hybrid-intervention group would have greater improments in the indices of heart-healthy behaviors than a control group. 2. A hybrid-intervention group would have greater improvements in the indices of heart-healthy behaviors than a mobile-app group. |
| Ethics approval(s) | Approved 23/09/2022, Korea University Institutional Review Board (145 Anam-ro Seongbuk-gu, Seoul, 02841, Korea, South; +82-2-3290-1137; kuirb@korea.ac.kr), ref: KUIRB-2022-0287-01 |
| Health condition(s) or problem(s) studied | Cardiovascular health promotion and prevention among community-dwelling individuals who are at risk for cardiovascular disease |
| Intervention | Current interventions as of 31/03/2025: The intervention is named as the "Community-based Heart-Healthy Lifestyle Promoting Program (i.e., HeartHELP program)". The HeartHELP program contains of three intervention modes: 1. General information for cardiovascular health 2. Mobile-application use 3. Motivational interveiwing counselling. The duration of the program is 12 weeks. The final sample size is 75, which will be randomly allocated into 25 in the control group, 25 in the mobile-app group, or 25 in the hybrid-intervention group. After the completion of participant recruitment (N = 75), we will create a participant list by the recruitment time order. A random allocation in the present study will be carried out by a principal investigator using age- and gender-stratified randomization. Random code lists will be generated by age- and gender-stratified groups, such as 20-29, 30-39, 40-49, 50-59, and 60-65 years groups by gender. Using the participant list, we will assign participants within a stratified group according to age- and gender – stratified random code lists. We have three study arms: The hybrid-intervention group, the mobile-app group, and the control group. The hybrid-intervention group will be received three intervention modes: 1) general information on cardiovascular health; 2) mobile-application use; and 3) motivational interviewing counselling. The mobile-app group will be received two intervention modes: 1) general information on cardiovascular health; and 2) mobile-application use. The control group will be received one intervention mode: 1) general information on cardiovascular health. The general information indicates the receiving of a brochure including contents of cardiovascular disease, cardiovascular risk factors, and general lifestyle change. The mobile-application use indicates an online intervention mode, i.e., the receiving of text messages, self-monitoring of their lifestyle behaviors, and the receiving of feedback messages based on the outcomes of behavioral practices. The motivational interviewing counselling indicates an offline intervention mode, i.e., customized individual counseling and group-wise counseling based on the principle of motivational interviewing. _____ Previous interventions as of 03/11/2022: The intervention is named as the "Community-based Heart-Healthy Lifestyle Promoting Program (i.e., HeartHELP program)". The HeartHELP program contains of three intervention modes: 1. General information for cardiovascular health 2. Mobile-application use 3. Motivational interveiwing counselling. The duration of the program is 12 weeks. The final sample size is 60, which will be randomly allocated into 20 in the control group, 20 in the mobile-app group, or 20 in the hybrid-intervention group. After the completion of participant recruitment (N = 60), we will create a participant list by the recruitment time order. A random allocation in the present study will be carried out by a principal investigator using age- and gender-stratified randomization. Random code lists will be generated by age- and gender-stratified groups, such as 20-29, 30-39, 40-49, 50-59, and 60-65 years groups by gender. Using the participant list, we will assign participants within a stratified group according to age- and gender – stratified random code lists. We have three study arms: The hybrid-intervention group, the mobile-app group, and the control group. The hybrid-intervention group will be received three intervention modes: 1) general information on cardiovascular health; 2) mobile-application use; and 3) motivational interviewing counselling. The mobile-app group will be received two intervention modes: 1) general information on cardiovascular health; and 2) mobile-application use. The control group will be received one intervention mode: 1) general information on cardiovascular health. The general information indicates the receiving of a brochure including contents of cardiovascular disease, cardiovascular risk factors, and general lifestyle change. The mobile-application use indicates an online intervention mode, i.e., the receiving of text messages, self-monitoring of their lifestyle behaviors, and the receiving of feedback messages based on the outcomes of behavioral practices. The motivational interviewing counselling indicates an offline intervention mode, i.e., customized individual counseling and group-wise counseling based on the principle of motivational interviewing. Previous interventions: The intervention is named as the "Community-based Heart-Healthy Lifestyle Promoting Program (i.e., HeartHELP program)". The HeartHELP program contains of three intervention modes: 1. General information for cardiovascular health 2. Mobile-application use 3. Motivational interveiwing counselling. The duration of the program is 12 weeks. The final sample size is 75, which will be randomly allocated into 25 in the control group, 25 in the mobile-app group, or 25 in the hybrid-intervention group. After the completion of participant recruitment (N = 75), we will create a participant list by the recruitment time order. A random allocation in the present study will be carried out by a principal investigator using age- and gender-stratified randomization. Random code lists will be generated by age- and gender-stratified groups, such as 20-29, 30-39, 40-49, 50-59, and 60-65 years groups by gender. Using the participant list, we will assign participants within a stratified group according to age- and gender – stratified random code lists. We have three study arms: The hybrid-intervention group, the mobile-app group, and the control group. The hybrid-intervention group will be received three intervention modes: 1) general information on cardiovascular health; 2) mobile-application use; and 3) motivational interviewing counselling. The mobile-app group will be received two intervention modes: 1) general information on cardiovascular health; and 2) mobile-application use. The control group will be received one intervention mode: 1) general information on cardiovascular health. The general information indicates the receiving of a brochure including contents of cardiovascular disease, cardiovascular risk factors, and general lifestyle change. The mobile-application use indicates an online intervention mode, i.e., the receiving of text messages, self-monitoring of their lifestyle behaviors, and the receiving of feedback messages based on the outcomes of behavioral practices. The motivational interviewing counselling indicates an offline intervention mode, i.e., customized individual counseling and group-wise counseling based on the principle of motivational interviewing. |
| Intervention type | Behavioural |
| Primary outcome measure | Heart-healthy behaviors, as measured by the Evaluation Tool of the managment behaviors of metabolic syndrome at pre- and post-intervention |
| Secondary outcome measures | Measured at pre- and post-intervention: 1. Heart-healthy self-efficacy by self-report questionnaire 2. Heart-healthy motivation by self-report questionnaire 3. Heart-healthy biophyscial factors (i.e., body mass index, waist circumference, blood pressure, fasting glucose, total-cholesterol, LDL-cholesterol, and HDL-cholesterol) measured by anthropometric and blood pressure measures, and blood sampling |
| Overall study start date | 01/08/2022 |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 75 |
| Key inclusion criteria | Community-dwelling adults who are at risk for cardiovascular disease, specifically having at least one component of metabolic syndrome according to the NCEP-ATP III. |
| Key exclusion criteria | Current exclusion criteria as of 31/03/2025: 1. Adults who were medically diagnosed with diabetes mellitus or cardiovascular diseases 2. Adults who were medically diagnosed with psychiatric disease including major depression or anxiety disorder 3. Adults having activity limitations 4. Adults with cognition problems 5. Adults who were not able to respond to self-reported questionnaire 6. Adults who were not able to use mobile application _____ Previous exclusion criteria: 1. Adults with antihypertensive, lipid-lowering medications, or hypoglycemics (including insulin injection) 2. Adults who were medically diagnosed with diabetes mellitus or cardiovascular diseases 3. Adults who were medically diagnosed with psychiatric disease including major depression or anxiety disorder 4. Adults having activity limitations 5. Adults with cognition problems 6. Adults who were not able to respond to self-reported questionnaire 7. Adults who were not able to use mobile application |
| Date of first enrolment | 17/10/2022 |
| Date of final enrolment | 03/02/2023 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seongbuk-gu
Seoul
02841
Korea, South
Sponsor information
University/education
145 Anam-ro, Seongbuk-gu
Seoul
02841
Korea, South
| Phone | +82-2-3290-5858 |
|---|---|
| tjjung84@korea.ac.kr | |
| Website | http://www.korea.ac.kr/mbshome/mbs/university/index.do |
"ROR" |
https://ror.org/047dqcg40 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Presentation of abstract in 2023 American Heart Association Scientific meeting. Publication in the Journal of Advanced Nursing |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the principal investigator (PI), Jina Choo, PhD, DrPH, RN (jinachoo@korea.ac.kr) when the PI decides to publicize the data. As of now, it is not possible to specify a specific time |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 01/04/2019 | 04/10/2022 | No | No | |
| Basic results | 31/03/2025 | 31/03/2025 | No | No |
Additional files
Editorial Notes
31/03/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The overall end date was changed from 31/08/2023 to 31/03/2025.
3. The interventions were changed.
4. The recruitment end date was changed from 04/11/2022 to 03/02/2023.
5. The plain English summary was updated to reflect these changes.
6. The target number of participants was changed from 60 to 75.
7. The total final enrolment was added.
8. The basic results have been uploaded as an additional file.
03/11/2022: The interventions have been updated.
02/11/2022: The following changes were made:
1. The overall trial start date has been changed from 18/08/2022 to 01/08/2022.
2. The target number of participants has been changed from 75 to 60 and the plain English summary was updated accordingly.
3. The recruitment end date has been changed from 03/11/2022 to 04/11/2022.
04/10/2022: Trial's existence confirmed by Korea University IRB.
