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Childhood ObesityNCT06394882

FamCe-HLP- Family-centered Obesity Management Program in Primary Care Settings

A study testing Family-Centered Healthy Lifestyle Program (FamCe-HLP) in people with Childhood Obesity and Family, run by Oman Ministry of Health at 4 sites in Oman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity, Family, Behavior, Health
What is being tested?
Family-Centered Healthy Lifestyle Program (FamCe-HLP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesOman
Study dates
18 Sep 2023to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Oman4 sites

  • Mabela Health Center

    Muscat, Muḩāfaz̧at Masqaţ, 123

  • Mabela South Health Center

    Muscat, Muḩāfaz̧at Masqaţ, 123

  • Mawaleh Health Center

    Muscat, Muḩāfaz̧at Masqaţ, 123

  • Mawaleh North Health Center

    Muscat, Muḩāfaz̧at Masqaţ, 123

Other trials in Oman

About this study

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.

Being tested
Family-Centered Healthy Lifestyle Program (FamCe-HLP)
Keywords
childhood obesity, family, management, primary care
Medical subject headings
Pediatric Obesity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family-Centered Healthy Lifestyle Program (FamCe-HLP)Behavioural

    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.

Study groups in NCT06394882
Study groupRoleWhat they receive
Intervention GroupExperimentalThe 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.
Receives: Behavioral: Family-Centered Healthy Lifestyle Program (FamCe-HLP)
Treatment as usualNo interventionParticipants in the control group will receive treatment as usual, which is the regular care provided by the center for adults and children with obesity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child's Adiposity

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

    Measured: Four time points in one year duration

  2. Mother's Adiposity (Body fat percentage)

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

    Measured: Four time points in one year duration

  3. 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

    Measured: Four time points in one year duration

  4. Mother's weight status (BMI)

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

    Measured: Four time points in one year duration

Secondary outcomes (10)

  1. 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

    Measured: Four time points in one year duration

  2. 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)

    Measured: Two time points in one year

  3. 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)

    Measured: Two time points in one year

  4. 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

    Measured: Four time points in one year duration

  5. 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

    Measured: Four time points in one year duration

  6. Child's obesity stage level

    Child's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician

    Measured: Four time points in one year duration

  7. Mother's obesity stage level

    Mother's obesity stage level will be assessed following the Edmonton obesity staging system evaluation by a family physician

    Measured: Four time points in one year duration

  8. Father's weight status (ripple effect

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

    Measured: Four time points in one year duration

  9. 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

    Measured: Four time points in one year duration

  10. 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

    Measured: Four time points in one year duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start18 Sep 2023
  3. Primary completion21 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06394882
Sponsor's protocol ID
RC/SR-CON/MCHH/22/02
Status last verified
Mar 2024
First submitted
6 Dec 2023
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Family-Centered Healthy Lifestyle Program (FamCe-HLP) in people with Childhood Obesity and Family, run by Oman Ministry of Health at 4 sites in Oman.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child's Adiposity (time frame: Four time points in one year duration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06394882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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