Lifestyle Medicine Health Education and Intervention Program "Family Central E-Health"

NCT ID: NCT06934083

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2022-06-01

Brief Summary

Participants will receive text messages at intervals set by preference but at least 2 times per week relating to Lifestyle Health Education for 6 months. The topics to be reviewed include: Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection. Participants will be asked to complete surveys regarding these topics at the beginning and end of the week; in addition, participants will self report to the study team vital signs (including blood pressure, blood glucose, total cholesterol, waist circumference, and body mass index (BMI)) at the beginning and end of the study. Although there is a chance participants may encounter some issues with the study procedures (possible breach of confidentiality, or issues with the study procedures), these risks are minimal. The study team will always keep information secure, and participants may decline to participate in any study procedures, or withdraw from the study, at any time.

One benefit from this study may be that participants may improve their overall health by learning more about healthy eating, improved physical activity, limiting/avoiding tobacco intake, improved sleep patterns, adequate stress management, and better social connection. Participation in this study is not required.

Detailed Description

Participants will be randomized (like the flip of coin) to one of two study groups. Based on the group assigned, participants will receive text messages which include either: 1) reminders of health education available through the patient portal of the electronic medical record for participant's child, or 2) briefs on six health education topics: nutrition, physical activity, sleep, tobacco avoidance, stress management, and social connection. No matter which group assigned, participants will attend one live or virtual group meeting to close the study.

For both groups, researchers will measure knowledge, attitudes and health habits before and after the program. Researchers will also request self-reports of health status (height, weight, waist size, Body Mass Index (BMI), blood pressure, blood sugar, and total cholesterol). Participants will provide the researchers with estimates of most recent blood pressure, total cholesterol, and blood glucose test if known. The study will include text message briefs received at least twice weekly for six months, and will include the following measures:

• General information (e.g., age, gender, education)
• Health knowledge & attitudes (e.g., heart disease, diabetes) & healthy lifestyle practices (e.g., diet, exercise)
• Health status (e.g., Blood pressure, BMI, etc.) The study team estimate that 142 people will enroll in the study.

For both groups, the following will be measured at the first visit (also called the "baseline visit" completed at the time of enrollment) and also at the last visit (during the live or virtual community celebration):

• Participant's health status (height, weight, waist size, Body Mass Index (BMI), blood pressure, blood sugar, and total cholesterol).
• Survey of knowledge, attitudes and health habits.

As described above, participants will be randomized to one of two groups:

1. If selected to be in the first group, participants will first receive a welcome text with a link to the patient portal for the electronic health record (of participant's child). Participants will then receive weekly reminders of health education (one reminder each week for 6 months), available through the patient portal of the electronic medical record (of participant's child). At least twice a week, participants will also complete surveys regarding participant's knowledge, attitudes and behaviors of the health education topics (these surveys will be delivered to their phone via text messages).

2. If selected to be in the second group, participants will begin receiving weekly text messages which include health education briefs on 6 different topics (one text message a week for 6 months). At least twice a week, participants will also complete surveys regarding participants' knowledge, attitudes and behaviors of the health education topics (these surveys will be delivered to participant's phone via text messages).

Conditions

Obesity; Life Style, Healthy; Behavioral Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

E-health education briefs

The e-health intervention group will receive health education briefs that will cover all six lifestyle modifications every 6 weeks. Over the 6-month study period, each lifestyle modification topic will be covered 4 times.

Group Type: EXPERIMENTAL

E-health education briefs

Intervention Type: BEHAVIORAL

Participants will be asked to complete self-administered questionnaire regarding the six healthy lifestyles delivered via text message to their cell phone. Then, during the six-month intervention, participants will receive text messages at intervals set by their preference but at least 2 times per week to ensure adequate space for education delivery and assessment through Likert scale text message surveys relating to Lifestyle Health Education topics including Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection. As to the clinical outcomes, self-reported blood pressure, blood glucose, total cholesterol, waist circumference, and body mass index (BMI) will be collected from the participants at enrollment and at the live or virtual community celebration at the close of the study.

Usual care

The usual care group will receive text messages directing caregivers to consult the electronic medical record patient portal of their child, which has a library of health literature, related to lifestyle behaviors, their child's lab results, and appointment reminders.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

E-health education briefs

Participants will be asked to complete self-administered questionnaire regarding the six healthy lifestyles delivered via text message to their cell phone. Then, during the six-month intervention, participants will receive text messages at intervals set by their preference but at least 2 times per week to ensure adequate space for education delivery and assessment through Likert scale text message surveys relating to Lifestyle Health Education topics including Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection. As to the clinical outcomes, self-reported blood pressure, blood glucose, total cholesterol, waist circumference, and body mass index (BMI) will be collected from the participants at enrollment and at the live or virtual community celebration at the close of the study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• family member has a child who is a current or former patient of Pediatric Mobile Clinic with a medical diagnosis of overweight/obese,
• defined as BMI percentile of 85% or above,
• age of the child is 6 months to 11 years old,
• family member is a primary caregiver to the child,
• family member over the age of 18 years,
• family member is not currently pregnant, and
• family member has a cell phone with Short Message Service (SMS) text message capability.

Exclusion Criteria

• family member has a terminal illness.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

UNTHSC

Locations

UNT Health Science Center

Fort Worth, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study protocol documents

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Cover page

View Document

Other Identifiers

2U54MD006882-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RF00187

Identifier Type: -

Identifier Source: org_study_id