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

NCT06934083 | Completed

• 2 other identifiers: RF001872U54MD006882-06
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Life Style, Healthy; Behavioral Changes

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Confidence in units of scale measure

  12 months

Other Outcomes (5)

• SMART goal

  12 months

• BMI in kg/m^2

  6 months

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

  6 months

Study Arms (2)

E-health education briefs

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

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.

E-health education briefs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• family member has a terminal illness.

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UNT Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina Robinson, MD

  UNTHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: April 18, 2025
• Study Start: November 15, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)