Promoting Health in Healthy Living Centres - a Clinical Study Among Children

NCT02290171 | Completed

• 1 other identifier: NCT02290171
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development and health of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate in a one-year intervention together with their parents, both at completion of the six months intervention and at long term follow up will have reduced their BMI-for-age z-score (Iso-BMI) and have adopted healthy habits. The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions.

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

• Iso-BMI

  Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects

  Change at 6 months, 1 year, 2 years

Secondary Outcomes (3)

• Physical activity level

  6 months, 1 and 2 years

• Dietary habits

  6 months, 1 and 2 years

• Self-perceived health

  6 months, 1 and 2 years

Other Outcomes (2)

• Autonomous regulation and perceived autonomy support

  6 months, 1 and 2 years

• Motor skills

  6 months, 1 and 2 years

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention groups start the intervention 6 months ahead of the control group.

Behavioral: Activity groups; Behavioral: Group based dietary counselling; Behavioral: Individual counselling

Delayed intervention group

NO INTERVENTION

The control groups will start intervention with 6 months delay

Interventions

Activity groups BEHAVIORAL

Children attend to activity groups weekly during the intervention periode.

Intervention group

Group based dietary counselling BEHAVIORAL

Parents attend to four sessions of group based dietary counselling

Intervention group

Individual counselling BEHAVIORAL

Parents attend to individual counselling focusing on parental skills and family structure

Intervention group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Iso-BMI\>25,
• able to participate in activity groups

You may not qualify if:

• Children being unable to participate in activity groups,
• parents not able to participate in group based and individual counseling

Sponsors & Collaborators

• Eivind Meland: lead
• University of Agder: collaborator

Study Sites (2)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

University of Agder

Kristiansand, Vest-Agder, 4604, Norway

Location

Related Publications (1)

• Stea TH, Vettore MV, Ovrebo B, Abildsnes E. Changes in dietary habits and BMI z-score after a 6-month non-randomized cluster-controlled trial among 6-12 years old overweight and obese Norwegian children. Food Nutr Res. 2023 Dec 12;67. doi: 10.29219/fnr.v67.9617. eCollection 2023.

  PMID: 38187797 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eivind Meland, MD, PhD

  Dept of Glob Publ Health and Primary Care, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 13, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

NO (2)