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Completed

NCT Number: NCT06934083

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNT Health Science Center

Fort Worth, Texas, 76107, United States

About this study

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:

  • 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).
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E-health education briefs

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.

Primary outcomes

  1. Motivation in units of scale measure

    Time frame: 12 months

    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.

Secondary outcomes

  1. Confidence in units of scale measure

    Time frame: 12 months

    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.

Other outcomes

  1. SMART goal

    Time frame: 12 months

    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.

  2. BMI in kg/m^2

    Time frame: 6 months

    self-reported body weight using provided weight scale and self-reported recall height

  3. Total Cholesterol in milligrams (mg) of cholesterol per deciliter (dL) of blood

    Time frame: 6 months

    self reported recall of cholesterol level

  4. Blood glucose in mg/dl (milligrams per deciliter)

    Time frame: 6 months

    self reported recall of blood sugar either from venipuncture or capillary stick

  5. Blood pressure in millimeters of mercury (mmHg)

    Time frame: 6 months

    self-reported recall of automated or manual systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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