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

NCT06394882 | Completed

• 1 other identifier: RC/SR-CON/MCHH/22/02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Childhood Obesity; Family; Behavior, Health; Lifestyle, Healthy

Keywords

childhood obesity; family; management; primary care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Child's daily caloric intake in kilocalories (24 dietary recall)

  Four time points in one year duration

• Child'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 intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)

  Two time points in one year

• Child's moderate to vigorous physical activity in minutes per day

  Four time points in one year duration

• Mother's moderate to vigorous physical activity in minutes per day

  Four time points in one year duration

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Treatment as usual

NO INTERVENTION

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.

Interventions

Family-Centered Healthy Lifestyle Program (FamCe-HLP) BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Ministry of Health: lead
• Sultan Qaboos University: collaborator

Study Sites (4)

Mabela Health Center

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

Mabela South Health Center

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

Mawaleh Health Center

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

Mawaleh North Health Center

Muscat, Muḩāfaz̧at Masqaţ, 123, Oman

Location

MeSH Terms

Conditions

Pediatric Obesity; Health Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Basma Al Yazeedi, PhD

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cluster Randomized controlled clinical trial to test the efficacy of a family-centered healthy lifestyle program on adiposity and weight status in mother-child dyads with overweight or obesity.

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: May 1, 2024
• Study Start: September 18, 2023
• Primary Completion: June 21, 2025
• Study Completion: June 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

OM (4)