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

Oman Ministry of Health

Status: Completed

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

Treatments: Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06394882

RC/SR-CON/MCHH/22/02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP)

Treatment as usual

No Intervention group

Description:

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.