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The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Susceptible to Future Overweight

2020년 5월 13일 업데이트: Berit Lilienthal Heitmann, Bispebjerg Hospital

Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.

Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in childhood is associated with psychological and social problems, low self-esteem, stigmatization and being teased and bullied by friends. Danish research suggests that the causes behind the increase in obesity occurrence are present already in early childhood, and that prevention of obesity therefore has to start early. Research has suggested that at least three sub-groups can be considered susceptible to develop obesity: Children with obesity among their 1st degree relatives; children with a high birth weight or children coming from socially disadvantaged families (low socioeconomic status). Earlier intervention programs has showed little effect in preventing excessive weight gain and knowledge on how to develop effective intervention programs that reduce overweight and obesity remains limited. It has been suggested that future prevention programs may be more successful if specifically targeting groups that are at high risk, as mention above, of excessive weight gain.

Based on these suggestions, the "Sund Start" project was initiated. The purpose of the study was to determine whether aiming prevention towards 2-6 years old Danish children who were yet normal weight, but were considered susceptible to develop overweight or obese could prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible to improve diet habits, increase physical activity, reduce stress and improve sleeping habits among children at high risk for later on overweight and obesity.

The "Sund Start" project will contribute with knowledge about whether targeting normal weight, predisposed children is effective in preventing overweight and obesity, and if reduced stress and improved sleep, should be considered important new obesity prevention tools. Moreover, the project will contribute with knowledge about how to change lifestyle and its effects on development of overweight and obesity in high risk Danish preschool children.

연구 개요

상세 설명

In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register.

After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight.

연구 유형

중재적

등록 (실제)

1202

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Frederiksberg, 덴마크, 2000
        • Parker Institute, Research Unit for Dietary Studies

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2년 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Born between 2004-2007
  • Born in 11 selected municipalities in the greater Copenhagen area
  • Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (> 4000 grams), maternal pre-pregnancy obesity (BMI > 28 kg/m^2), or maternal low education (<= 10 years)
  • Normal weight at baseline examination

Exclusion Criteria:

  • Moved to another municipality after birth,
  • Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry
  • No permanent address
  • Lived in a children's home
  • Had died
  • Had emigrated
  • Registered in the Danish Central Person Registry as being disappeared or had unknown life status
  • Not speaking Danish
  • Overweight (including obesity) at baseline examination

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Improved lifestyle
The intervention group was offered up to 10 individual consultations focusing on improving diet, physical activity and sleep habits and reducing stress. Moreover, the intervention group was offered participation in monthly cooking classes and playing arrangements
간섭 없음: Control group
The control group was seen at baseline and follow-up, but not in between.
간섭 없음: Shadow group
The shadow group was followed in registers exclusively

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Anthropometric measurements
기간: 1.3 years

Changes between baseline and 1.3 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD Waist circumference in cm Hip circumference in cm Sum of four skinfolds (biceps, triceps, subscapular and suprailiac) in cm Body composition measured by bio-electrical impedance

1.3 years
Anthropometric measurements
기간: 5 years

Changes between baseline and 5 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD

5 years
Anthropometric measurements
기간: 10 years

Changes between baseline and 10 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD

10 years

2차 결과 측정

결과 측정
측정값 설명
기간
Dietary intake
기간: 1.3 years
Four day dietary record completed Wednesday-Saturday
1.3 years
Priority of serving fruit and vegetables
기간: 1.3 years
How high do you prioritize that fruit and vegetables are served at the meals? (Scale from 1 to 4, 1 being low and 4 being high. Higher values considered better outcome)
1.3 years
Physical activity
기간: 1.3 years
Children's Physical Activity Questionnaire (C-PAQ. 7-day recording of sports, games and leisure time activities outside daycare. The response options were indicated by doing a particular activity ("yes" or "no") and by an indication of total time used on the activity during the week (minutes per week). All minutes per week were summed to obtain an indication of overall physical activity level. Higher values considered better outcome)
1.3 years
Sleep duration
기간: 1.3 years
7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)
1.3 years
Child stress level
기간: 1.3 years
Measured concentration of cortisol in hair samples
1.3 years
Parental stress level
기간: 1.3 year
Measured concentration of cortisol in hair samples
1.3 year
Sleep quality
기간: 1.3 year
Child's sleep is considered (calm all night, a little disturbed, disturbed with occasional awakenings, very disturbed with several awakenings. Calm all night considered best outcome).
1.3 year
Child stress level
기간: 1.3 year
Strengths and Difficulties Questionnaire (SDQ). Scored 0-2 and summed to Total Difficulties score (0-40, lower score indicate better outcome), and Prosocial Behavior score (0-10, lower score indicate worst outcome)
1.3 year
Parental stress level
기간: 1.3 years
Modified version of the Swedish Parental Stress Index (PSI). Each question was scored between 0 and 2 (0 considered best score and 2 the worst), according to its estimated indication of an overall stress level. Analysis of intercorrelations among the 10 questions and a principal component analysis suggested that 9 of the 10 questions could be added together to get a score for the overall family stress level (0-18)
1.3 years
Daily physical activity: Enjoys being active
기간: 1.3 years
If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)
1.3 years
Meal habits: Eating breakfast together
기간: 1.3 years
How many times per week does the family eat breakfast together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
1.3 years
Meal habits: Eating dinner together
기간: 1.3 years
How many times per week does the family eat dinner together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
1.3 years
Meal habits: Mealtime situation
기간: 1.3 years
How would you describe the meals with the child (Very conflictive, little conflictive, very cozy, little cozy, don't know. Very cozy considered best outcome).
1.3 years
Meal habits: Pickiness
기간: 1.3 years
How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).
1.3 years
Meal habits: Appetite
기간: 1.3 years
How would you describe your child's appetite (Too big appetite, good appetite, normal appetite, too small appetite, don't know. Normal appetite considered best outcome).
1.3 years
Sleep quality: Difficulties falling asleep
기간: 1.3 years
Difficulties falling asleep (yes/no. No considered best outcome)
1.3 years
Sleep quality: Difficulties waking up
기간: 1.3 years
Difficulties waking up (yes/no. No considered best outcome)
1.3 years
Sleep quality: Sleep onset latency
기간: 1.3 years
Sleep onset latency (numerical. Lower values considered better outcome)
1.3 years
Sleep quality: Bedtime routines
기간: 1.3 years
Routine activities before bedtime (No, < 1/week, 1-2 times/week, 3-4 times/week, 5-6 times/week, every day. Every day considered best outcome)
1.3 years
Sleep quality: Joining parents' bed
기간: 1.3 years
Child joining parents' bed (yes/no. If yes, how often (< 1/month, 1-3 times/month,1-3 times/week, 4-6 times/week, every night)
1.3 years
Sleep quality: Falling asleep
기간: 1.3 years
Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)
1.3 years
Sleep quality: Dreams
기간: 1.3 years
Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)
1.3 years
Daily physical activity: Means of transportation
기간: 1.3 years
Means of transportation to and from day-care, and frequency (Walk, strolling, bike on its own, biked by parent, and bus, train or car, number of times per week (1,2,3,4 or 5. Walking or biking on its own considered best outcome).
1.3 years
Daily physical activity: Activity compared to other children
기간: 1.3 years
How active is the child compared to other children at similar age? (as active, somewhat active, very active, don't know. Very active considered best outcome)
1.3 years
Daily physical activity: Activity with parents
기간: 1.3 years
Frequency of which one or both parents were physically active with the child (once per week, 2-4 times per week, 5-7 times per week, multiple times per day. Multiple times per day considered best outcome)
1.3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Berit L Heitmann, Professor, Parker Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 5월 1일

기본 완료 (실제)

2012년 8월 1일

연구 완료 (실제)

2018년 6월 1일

연구 등록 날짜

최초 제출

2012년 3월 31일

QC 기준을 충족하는 최초 제출

2012년 4월 20일

처음 게시됨 (추정)

2012년 4월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 13일

마지막으로 확인됨

2020년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Tryg-7984-07

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