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

NCT ID: NCT06394882

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Family-Centered Healthy Lifestyle Program (FamCe-HLP)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: collaborator

Oman Ministry of Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Basma Al Yazeedi, PhD

Role: PRINCIPAL_INVESTIGATOR

Sultan Qaboos University

Locations

Mabela Health Center

Muscat, Muḩāfaz̧at Masqaţ, Oman

Mabela South Health Center

Muscat, Muḩāfaz̧at Masqaţ, Oman

Mawaleh Health Center

Muscat, Muḩāfaz̧at Masqaţ, Oman

Mawaleh North Health Center

Muscat, Muḩāfaz̧at Masqaţ, Oman

Countries

Oman

Other Identifiers

RC/SR-CON/MCHH/22/02

Identifier Type: -

Identifier Source: org_study_id