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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity; Lifestyle, Healthy; Family; Behavior, Health
• Intervention / Treatment: Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman, 123
    • Mabela Health Center
  • Muscat, Oman, 123
    • Mabela South Health Center
  • Muscat, Oman, 123
    • Mawaleh Health Center
  • Muscat, Oman, 123
    • Mawaleh North Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The program will provide a seven-month program comprising two primary therapies: a three-month intensive behavioral therapy (IBT) and a four-month maintenance behavioral therapy (MBT). The three-month IBT will involve 12-week visits and exercise sessions. The program will encompass in-person (clinic/ health center) and online (telehealth) 12-weekly visits. The 60-minute consultations and booster sessions will be provided by a qualified multidisciplinary team (obesity nurse, psychologist, nutritionist, and physiotherapist), each consulting in their expertise. In collaboration with the physical education and sports science department at Sultan Qaboos University, mothers in the intervention group will be provided exercise sessions based on their individual metabolic and physiological parameters. The maintenance behavioral therapy will start one month after the end of the IBT and will involve four monthly support meetings on a group level.	Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP); A multidisciplinary-led healthy lifestyle program will provide a seven-month program comprising two primary therapies: a three-month intensive behavioral therapy (IBT) and a four-month maintenance behavioral therapy (MBT). The program will run on scheduled days using one of the center's offices for the IBT and the center's seminar room for the MBT.
No Intervention: Treatment as usual; Participants in the control group will receive treatment as usual, which is the regular care provided by the center for adults and children with obesity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's Adiposity	Child's body fat percentage will be determined through a bioelectrical impedance analysis scale	Four time points in one year duration
Mother's Adiposity (Body fat percentage)	Mother's body fat percentage will be determined through a bioelectrical impedance analysis scale	Four time points in one year duration
Child's weight status (BMI z score)	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	Four time points in one year duration
Mother's weight status (BMI)	Mother's weight and height will be combined to report BMI in kg/m^2	Four time points in one year duration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oman Ministry of Health
• Collaborators: Sultan Qaboos University
• Investigators: Principal Investigator: Basma Al Yazeedi, PhD, Sultan Qaboos University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): June 21, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: family; childhood obesity; primary care; management
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: RC/SR-CON/MCHH/22/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No