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| Name | Class |
|---|---|
| Sultan Qaboos University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Treatment as usual | No Intervention | Participants in the control group will receive treatment as usual, which is the regular care provided by the center for adults and children with obesity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-Centered Healthy Lifestyle Program (FamCe-HLP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child's Adiposity | Child's body fat percentage will be determined through a bioelectrical impedance analysis scale | Four time points in one year duration |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basma Al Yazeedi, PhD | Sultan Qaboos University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mabela Health Center | Muscat | Muḩāfaz̧at Masqaţ | 123 | Oman | ||
| Mabela South Health Center |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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Child's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ) |
| Two time points in one year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Muscat |
| Muḩāfaz̧at Masqaţ |
| 123 |
| Oman |
| Mawaleh Health Center | Muscat | Muḩāfaz̧at Masqaţ | 123 | Oman |
| Mawaleh North Health Center | Muscat | Muḩāfaz̧at Masqaţ | 123 | Oman |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |