Clinical trial NCT06394882: FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings
Official title: FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity
Family
Behavior, Health
Lifestyle, Healthy
Keywords: childhood obesity
family
management
primary care
Lead sponsor: Oman Ministry of Health
Sponsor class: OTHER_GOV
Collaborators: name: Sultan Qaboos University
First posted: 2024-05-01
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Child's Adiposity
timeFrame: Four time points in one year duration
measure: Mother's Adiposity (Body fat percentage)
timeFrame: Four time points in one year duration
measure: Child's weight status (BMI z score)
timeFrame: Four time points in one year duration
measure: Mother's weight status (BMI)
timeFrame: Four time points in one year duration
Secondary outcomes:
measure: Child's daily caloric intake in kilocalories (24 dietary recall)
timeFrame: Four time points in one year duration
measure: Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)
timeFrame: Two time points in one year
measure: Mother's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)
timeFrame: Two time points in one year
measure: Child's moderate to vigorous physical activity in minutes per day
timeFrame: Four time points in one year duration
measure: Mother's moderate to vigorous physical activity in minutes per day
timeFrame: Four time points in one year duration
measure: Child's obesity stage level
timeFrame: Four time points in one year duration
measure: Mother's obesity stage level
timeFrame: Four time points in one year duration
measure: Father's weight status (ripple effect
timeFrame: Four time points in one year duration
measure: Child's 18 and above years old sibling weight status (ripple effect)
timeFrame: Four time points in one year duration
measure: Child's under 18 years old sibling weight status (ripple effect)
timeFrame: Four time points in one year duration
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Mabela Health Center
city: Muscat
country: Oman
facility: Mabela South Health Center
city: Muscat
country: Oman
facility: Mawaleh Health Center
city: Muscat
country: Oman
facility: Mawaleh North Health Center
Study officials:
affiliation: Sultan Qaboos University
name: Basma Al Yazeedi, PhD
role: PRINCIPAL_INVESTIGATOR
References: