FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings

Not Applicable

Completed

• Conditions: Behavior, Health; Childhood Obesity; Family; Lifestyle, Healthy

• Registration Number: NCT06394882
• Lead Sponsor: Oman Ministry of Health

Brief Summary

This clinical trial aims to compare the adiposity and weight status among mother-child dyads with overweight or obesity who receive the Fam-Ce-HLP intervention with the mother-child dyads with overweight or obesity who did not receive the intervention. The main question\[s\] it aims to answer are:

* Is there a significant difference in the adiposity and weight status of mother-child dyads with overweight or obesity who received the Fam-Ce-HLP intervention compared with the mother-child dyads with overweight or obesity who did not receive the intervention?

* Is there a significant difference in the health behaviors, obesity stage level, and ripple effect of mother-child dyads with overweight or obesity who received the Fam-Ce-HLP intervention compared with the mother-child dyads with overweight or obesity who did not receive the intervention? Participants will be asked to attend a seven-month program comprising two primary therapies: a three-month intensive behavioral therapy (IBT) and a four-month maintenance behavioral therapy (MBT).

Researchers will compare the intervention group with the treatment-as-usual group (control group) to see if there is a difference in adiposity, weight status, health behaviors, obesity stage level, and ripple effect.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-18
• Study First Submitted: 2023-12-06
• Status Verified: 2024-03
• Study First Submitted QC: 2024-04-28
• Study First Posted: 2024-05-01
• Primary Completion: 2025-06-21
• Study Completion: 2025-06-30
• Last Update Submitted: 2025-08-03
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Mother and child dyads with the presence of overweight or obesity (stages 0 to 2)
• Being Omani
• Mother age 18 years or more
• Child age 6 to 12 years
• Mother understand, write, and read in Arabic
• Eligible to receive the health center's services based on their area of residence
• Has medical clearance to participate in individual exercise sessions
• Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria

• Mother or child currently receiving an obesity-related program
• Mother or child currently on obesity-related procedures
• Mother or child with a history of obesity-related surgeries in the last 5 years
• Mother or child is in obesity stage 3 or 4 based on the Edmonton obesity staging system
• Mother who is pregnant during the study time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child's Adiposity	Four time points in one year duration	Child's body fat percentage will be determined through a bioelectrical impedance analysis scale
Child's weight status (BMI z score)	Four time points in one year duration	Child's weight and height will be combined to report BMI in kg/m\^2 and then BMI z-scores will be determined according to the 2007 World Health Organization growth charts
Mother's weight status (BMI)	Four time points in one year duration	Mother's weight and height will be combined to report BMI in kg/m\^2
Mother's Adiposity (Body fat percentage)	Four time points in one year duration	Mother's body fat percentage will be determined through a bioelectrical impedance analysis scale

Secondary Outcome Measures

Name	Time	Method
Child's under 18 years old sibling weight status (ripple effect)	Four time points in one year duration	Child's under 18 years old sibling weight and height will be combined to report BMI in kg/m\^2 and then BMI z-scores will be determined according to the 2007 World Health Organization growth charts
Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)	Two time points in one year	Child's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)
Child's moderate to vigorous physical activity in minutes per day	Four time points in one year duration	Child's physical activity level will be determined through calculating the moderate to vigorous physical activity in minutes per day by wearing accelerometers (Actigraph devices) for seven days
Mother's moderate to vigorous physical activity in minutes per day	Four time points in one year duration	Mother's physical activity level will be determined through calculating the moderate to vigorous physical activity in minutes per day by wearing accelerometers (Actigraph devices) for seven days
Child's 18 and above years old sibling weight status (ripple effect)	Four time points in one year duration	Child's over 18 years old sibling weight and height will be combined to report BMI in kg/m\^2
Mother's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)	Two time points in one year	Mother's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)
Child's obesity stage level	Four time points in one year duration	Child's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician
Father's weight status (ripple effect	Four time points in one year duration	Father's weight and height will be combined to report BMI in kg/m\^2
Child's daily caloric intake in kilocalories (24 dietary recall)	Four time points in one year duration	Child's 24 dietary recall for three non-consecutive days will be collected using myfood24 nutritional analysis software
Mother's obesity stage level	Four time points in one year duration	Mother's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician

Trial Locations

Locations (4)

Mabela Health Center; 🇴🇲 Muscat, Oman

Mabela South Health Center; 🇴🇲 Muscat, Oman

Mawaleh Health Center; 🇴🇲 Muscat, Oman

Mawaleh North Health Center; 🇴🇲 Muscat, Oman