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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06394882
Other study ID # RC/SR-CON/MCHH/22/02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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