FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings
- Conditions
- Behavior, HealthChildhood ObesityFamilyLifestyle, Healthy
- Interventions
- Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP)
- Registration Number
- NCT06394882
- Lead Sponsor
- Oman Ministry of Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Family-Centered Healthy Lifestyle Program (FamCe-HLP) 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.
- Primary Outcome Measures
Name Time Method Child's Adiposity Four time points in one year duration Child's body fat percentage will be determined through a bioelectrical impedance analysis scale
Child's weight status (BMI z score) Four time points in one year duration 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
Mother's weight status (BMI) Four time points in one year duration Mother's weight and height will be combined to report BMI in kg/m\^2
Mother's Adiposity (Body fat percentage) Four time points in one year duration Mother's body fat percentage will be determined through a bioelectrical impedance analysis scale
- Secondary Outcome Measures
Name Time Method Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein) Two time points in one year Child's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)
Child's moderate to vigorous physical activity in minutes per day Four time points in one year duration 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
Mother's moderate to vigorous physical activity in minutes per day Four time points in one year duration 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
Child's 18 and above years old sibling weight status (ripple effect) Four time points in one year duration Child's over 18 years old sibling weight and height will be combined to report BMI in kg/m\^2
Mother's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein) Two time points in one year Mother's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)
Child's obesity stage level Four time points in one year duration Child's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician
Father's weight status (ripple effect Four time points in one year duration Father's weight and height will be combined to report BMI in kg/m\^2
Child's under 18 years old sibling weight status (ripple effect) Four time points in one year duration 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
Child's daily caloric intake in kilocalories (24 dietary recall) Four time points in one year duration Child's 24 dietary recall for three non-consecutive days will be collected using myfood24 nutritional analysis software
Mother's obesity stage level Four time points in one year duration Mother's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician
Trial Locations
- Locations (4)
Mawaleh North Health Center
🇴🇲Muscat, Oman
Mabela Health Center
🇴🇲Muscat, Oman
Mabela South Health Center
🇴🇲Muscat, Oman
Mawaleh Health Center
🇴🇲Muscat, Oman