Childhood Obesity Clinical Trial
Official title:
FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Oman Ministry of Health | Sultan Qaboos University |
Oman,
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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