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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394882
• Other study ID #: RC/SR-CON/MCHH/22/02
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Oman Ministry of Health
• Contact: Basma Al Yazeedi, PhD
• Phone: 9964 1905
• Email: basma84[@]squ.edu.om
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Health
• Childhood Obesity
• Family
• Lifestyle, Healthy
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Oman	Mabela Health Center	Muscat
Oman	Mabela South Health Center	Muscat
Oman	Mawaleh Health Center	Muscat
Oman	Mawaleh North Health Center	Muscat

Sponsors (2)

Lead Sponsor	Collaborator
Oman Ministry of Health	Sultan Qaboos University

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child's Adiposity	Child's body fat percentage will be determined through a bioelectrical impedance analysis scale	Four time points in one year duration
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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