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Completed

NCT Number: NCT06394882

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.

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Key information

Conditions

Childhood Obesity Behavior Behavior, Health Body Weight Family Health Behavior Lifestyle, Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mabela Health Center, Muscat, Muḩāfaz̧at Masqaţ, Oman

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Child's Adiposity

    Time frame: Four time points in one year duration

    Child's body fat percentage will be determined through a bioelectrical impedance analysis scale

  2. Mother's Adiposity (Body fat percentage)

    Time frame: Four time points in one year duration

    Mother's body fat percentage will be determined through a bioelectrical impedance analysis scale

  3. Child's weight status (BMI z score)

    Time frame: 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

  4. Mother's weight status (BMI)

    Time frame: Four time points in one year duration

    Mother's weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Child's daily caloric intake in kilocalories (24 dietary recall)

    Time frame: 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

  2. Child's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)

    Time frame: Two time points in one year

    Child's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)

  3. Mother's food frequency intake of main food groups in grams (grains, fruits, vegetables, dairy, protein)

    Time frame: Two time points in one year

    Mother's food frequency of main food groups will be assessed through a semiquantitative food frequency questionnaire (FFQ)

  4. Child's moderate to vigorous physical activity in minutes per day

    Time frame: 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

  5. Mother's moderate to vigorous physical activity in minutes per day

    Time frame: 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

  6. Child's obesity stage level

    Time frame: 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

  7. Mother's obesity stage level

    Time frame: 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

  8. Father's weight status (ripple effect

    Time frame: Four time points in one year duration

    Father's weight and height will be combined to report BMI in kg/m^2

  9. Child's 18 and above years old sibling weight status (ripple effect)

    Time frame: 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

  10. Child's under 18 years old sibling weight status (ripple effect)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Collaborators

  • Sultan Qaboos University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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