Clinical trial NCT06934083: Lifestyle Medicine Health Education and Intervention Program "Family Central E-Health"
Official title: A Novel Family E-Health Intervention Process To Reduce Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Life Style, Healthy
Behavioral Changes
Keywords: obesity
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-04-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized control study will examine knowledge, attitudes, and healthy lifestyle practices regarding six "Lifestyle Medicine Health Education" topics among caregivers of Pediatric patients. In addition, clinical outcomes such as blood pressure, blood glucose, total cholesterol, waist circumference, and Body Mass Index (BMI) will be assessed; and the study will assess the change in outcomes from baseline to completion of this program. After enrollment, the study team will deliver a scale and a tape measure to the caregiver at the address of their choice. The participants' biometric measurements will be submitted via our text-messaging platform. Participants will be assigned into one of two research arms a) the e-health intervention group or b) a control group of usual care. All participants will engage in the study with non-web- based, two-way text messaging via their personal cell phone.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Motivation in units of scale measure
timeFrame: 12 months
Secondary outcomes:
measure: Confidence in units of scale measure
timeFrame: 12 months
Other outcomes:
measure: SMART goal
timeFrame: 12 months
measure: BMI in kg/m^2
timeFrame: 6 months
measure: Total Cholesterol in milligrams (mg) of cholesterol per deciliter (dL) of blood
timeFrame: 6 months
measure: Blood glucose in mg/dl (milligrams per deciliter)
timeFrame: 6 months
measure: Blood pressure in millimeters of mercury (mmHg)
timeFrame: 6 months
Locations:
city: Fort Worth
country: United States
facility: UNT Health Science Center
state: Texas
Study officials:
affiliation: UNTHSC
name: Christina Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: