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

A Novel Family E-Health Intervention Process To Reduce Childhood Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Life Style, Healthy; Behavioral Changes
• Intervention / Treatment: Behavioral: E-health education briefs

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).

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76107
      • UNT Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation in units of scale measure	10-point Likert scale (minimum of 1, maximum of 10, 10 representing highest level of motivation) of transtheoretical stage of change used to assess motivation to achieve participant derived SMART goal each week for 6 months then at 3-month intervals for 2 follow-up check-ins.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confidence in units of scale measure	10-point Likert scale (minimum of 1, maximum of 10, 10 representing highest level of confidence) of transtheoretical stage of change used to assess confidence to achieve participant derived SMART goal each week for 6 months then at 3-month intervals for 2 follow-up check-ins.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMART goal	Participant created goal that is specific, measurable, achievable, and time bound. Goal is related to lifestyle behavior modifications with assessment of achievement each week for 6 months then assessed at 3-month intervals for 6 following months. This is qualitative data that has no minimum, maximum, or standardization of better vs. worse.	12 months
BMI in kg/m^2	self-reported body weight using provided weight scale and self-reported recall height	6 months
Total Cholesterol in milligrams (mg) of cholesterol per deciliter (dL) of blood	self reported recall of cholesterol level	6 months
Blood glucose in mg/dl (milligrams per deciliter)	self reported recall of blood sugar either from venipuncture or capillary stick	6 months
Blood pressure in millimeters of mercury (mmHg)	self-reported recall of automated or manual systolic and diastolic blood pressure	6 months

Collaborators and Investigators

• Sponsor: University of North Texas Health Science Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Christina Robinson, MD, UNTHSC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: RF00187; 2U54MD006882-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All study-related materials and documentation will only be accessible to the study personnel. Completed questionnaires will be placed into locked file cabinets in the office of the PI. Clinical outcomes recorded through a shared Microsoft excel drive will only be accessible to key study personnel.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No