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Completed

NCT Number: NCT01198847

Early Stockholm Obesity Prevention Program

To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

1 year–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Stcokholm, 141 86, Sweden

About this study

Early STOPP project wants to promote good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.

Background Life is in constant change and affects our habits. In many ways this is positive but it also contributes to less favorable health factors. For example, take the car instead of cycling, take the lift instead of the stairs. This makes us less active in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.

Good treatment methods for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.

In Early STOPP project we study food, physical activity and sleep habits in the families with a little child. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • one obese or two overweight parents, 1 year old child

Exclusion criteria

  • weight effecting diseases

Treatment and study plan

Dietary, physical activity and sleeping

Behavioral

The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed.

The Low intensity arm will only receive written information and no direct face to face support

Primary outcomes

  1. Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention

    Time frame: 5 years

    Weight gain, reflected in BMI sds will reflect if the intervention has been successful

Secondary outcomes

  1. sleeping behavior

    Time frame: 5 years

    sleeping duration will be monitored to study its effect on intervention

  2. biomarkers

    Time frame: 5 years

    such as bacterial population in feces, markers in blood and in saliva

  3. physical activity and sedentary behaviour

    Time frame: 5 years

    physical activity and sedentary behavious will be monitored during the intervention

  4. dietary intake

    Time frame: 5 years

    changes in dietary habits and behaviour will be monitored

  5. socioeconomic factors

    Time frame: 5 years

    factors effecting obesity development will be assessed in order to understand their impact on intervention

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity

Acronym: EarlySTOPP

Important dates

Study start
2010
Primary completion
2014
Study completion
2019
First posted
Sep 10, 2010
Registry last updated
Aug 14, 2019

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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