Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children

NCT01087411 | Withdrawn

• 2 other identifiers: STOPP-82008/1116-31/2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study whether a targeted intervention can increase physical activity in inactive 8-yr old children and how it affects secondary measures such as metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI, body composition and aerobic work-capacity.

Conditions

Cardiovascular Risk Factors; Metabolic Risk Factors; Sedentary Lifestyle; Overweight

Keywords

accelerometry; physical activity; obesity; children; cardiovascular risk markers; metabolic risk markers; DXA; obesity prevention; omega 3; fish liver oil; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• Change in level of physical activity

  Physical activity, is measured with tri-axis accelerometers of the brand Actigraph model GT3X. Data is collected every 10 seconds during 7 consecutive whole days. It is the most feasible and precise method for the purpose.

  screening, 0 and 15 weeks and 12 months

Secondary Outcomes (7)

• Body composition

  0 and 15 weeks

• Cardiovascular risk markers

  0 and 15 seeks

• BMI (Body Mass Index)

  0 and 15 weeks

• Quality of life scale

  0 and 15 weeks

• Self reported motor skills

  0 and 15 weeks

Study Arms (4)

Motivational Interviewing and omega 3

EXPERIMENTAL

This arm is the group that receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.

Behavioral: Motivational Interviewing; Behavioral: Physical activity; Dietary Supplement: Supplementation with fish liver oli capsules

Motivational interviewing and placebo

EXPERIMENTAL

This arm is the group that receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.

Behavioral: Motivational Interviewing; Behavioral: Physical activity; Dietary Supplement: Placebo oil capsules

Control and omega 3

EXPERIMENTAL

This arm is the group that does not receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.

Dietary Supplement: Supplementation with fish liver oli capsules

Control and placebo

PLACEBO COMPARATOR

This arm is the group that does not receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.

Dietary Supplement: Placebo oil capsules

Interventions

Motivational Interviewing BEHAVIORAL

The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.

Motivational Interviewing and omega 3; Motivational interviewing and placebo

Physical activity BEHAVIORAL

Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.

Motivational Interviewing and omega 3; Motivational interviewing and placebo

Supplementation with fish liver oli capsules DIETARY_SUPPLEMENT

This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.

Control and omega 3; Motivational Interviewing and omega 3

Placebo oil capsules DIETARY_SUPPLEMENT

This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.

Control and placebo; Motivational interviewing and placebo

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.

You may not qualify if:

• Family not being able to participate in the program or take part in at least the physical activity assessment.
• Morbidities that affects the outcome parameters.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics.

Huddinge, Södermanland County, 14186, Sweden

Location

MeSH Terms

Conditions

Sedentary Behavior; Overweight; Motor Activity; Obesity

Interventions

Motivational Interviewing; Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pernilla Danielsson Liljeqvist, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: October 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

SE (1)