Behavior, Health, Childhood Obesity, Family, Lifestyle, Healthy
Conditions
Keywords
childhood obesity, family, management, primary care
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.
Interventions
BEHAVIORALFamily-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.
Sponsors
Sultan Qaboos University
Oman Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child's Adiposity | Four time points in one year duration | Child's body fat percentage will be determined through a bioelectrical impedance analysis scale |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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) |
| 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 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 |
Countries
Oman
Outcome results
None listed