FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Child's Adiposity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention Group
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.
干预措施: Family-Centered Healthy Lifestyle Program (FamCe-HLP) (Behavioral)
Treatment as usual
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.
结局指标
主要结局
Child's Adiposity
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Four time points in one year duration
Mother's body fat percentage will be determined through a bioelectrical impedance analysis scale
次要结局
- Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)(Two time points in one year)
- Child's moderate to vigorous physical activity in minutes per day(Four time points in one year duration)
- Mother's moderate to vigorous physical activity in minutes per day(Four time points in one year duration)
- Child's 18 and above years old sibling weight status (ripple effect)(Four time points in one year duration)
- Mother's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)(Two time points in one year)
- Child's obesity stage level(Four time points in one year duration)
- Father's weight status (ripple effect(Four time points in one year duration)
- Child's under 18 years old sibling weight status (ripple effect)(Four time points in one year duration)
- Child's daily caloric intake in kilocalories (24 dietary recall)(Four time points in one year duration)
- Mother's obesity stage level(Four time points in one year duration)