A Multifaceted Community-Family-Mother-Child Intervention Study for the Prevention of Childhood Obesity: The Life Tree Study
The objective of this study is to evaluate the effectiveness of a multifaceted community-family-mother-child (CFMC) intervention to prevent childhood overweight and obesity (OWO) and to evaluate the safety, feasibility, and cost-effectiveness of implementing the CFMC intervention as a sustainable stakeholders-informed integrated approach to childhood OWO prevention in healthcare facilities and schools in China.
Overview
- Acronym
- SCHeLTI-LIFE TREE
- Website
- SCHeLTI-LIFE TREE
- Investigators
-
- Contacts
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General Design
- Study design
- Clinical trial
- Start - End Year
- 2019 - 2028
- General Information on Follow Up (profile, frequency)
-
Women can be recruited either starting at preconception or in the first trimester. After the baseline preconception collection, women who were not pregnant at the time of recruitment are followed up at most three times within one year of enrollment or until conception. Then mothers are followed up twice during pregnancy (15 to 28 weeks and 29 to 36 weeks), once at delivery, and seven times postpartum (at 3, 6, 12, 24, 36, 48, and 60 months). After the baseline preconception collection, fathers are followed up once at pregnancy (29 to 36 weeks). After delivery, children are followed up six times postpartum (at 3, 6, 12, 24, 36, 48, and 60 months).
- Recruitment Target
-
- Families
- Number of Participants
- 13,500
- Number of Participants with Biological Samples
- 13,500
- Supplementary information about number of participants
-
Mothers: 4500 participants
Fathers: 4500 participants
Children: 4500 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Marker Papers
Wu Y, Marc I, Bouchard L, et al. Study protocol for the Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI): a multicentre, cluster-randomised, parallel-group, superiority trial of a multifaceted community-family-mother-child intervention to prevent childhood overweight and obesity. BMJ Open. 2021;11(4):e045192.
PUBMED 33795307Supplementary Information
More information on the HeLTI consortium is available at https://helti.org/
Timeline
Populations
SCHeLTI-LIFE TREE - Mothers - Intervention
The population is composed of women between 20 to 42 years of age who are: registered Shanghai residents, married to a registered Shanghai resident, or non-residents but have lived in Shanghai for at least 5 years, less than 14 weeks pregnant with one child, and planning to deliver in a participating study hospital. In the intervention group, participants get one-on-one sessions with a healthcare professional, group educational activities and social support, community-based activities, individualized text messages, access to usual care, and motivational web-based tools and apps for self-monitoring of lifestyle goals.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
20
- Maximum age
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42
- Pregnant Women
-
- First trimester
- Countries
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- China
- Territory
- Shanghai
- Health Status
-
- Women are excluded from the study if they have HIV, Hepatitis B, Hepatitis C, major heart conditions, thalassemia major, cystic fibrosis, pre-existing type 1 diabetes mellitus, type 2 diabetes mellitus, or chronic medication-dependant hypertension.
- Other Criteria
- Participating women must be Mandarin speakers and less than 14 weeks pregnant. Women are excluded if they plan to move out participating Shanghai districts chosen for the study within five years, abuse drugs, or have multiple pregnancies.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from one of the 42 maternal child health units located within the four designated Shanghai districts.
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
- Supplementary information about number of participants
-
Nonpregnant women: 900 participants
Pregnant women (< 14 weeks): 1350 participants50% of 900 nonpregnant participants are expected to achieve a viable pregnancy within 1 year of enrolment and continue prenatal follow-up with the study.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SCHeLTI-LIFE TREE - Mothers Intervention - Preconception Baseline |
|
|
2019 | 2022 |
| 1 | SCHeLTI-LIFE TREE - Mothers Intervention - Preconception 3 months after enrolment |
|
2019 | 2022 | |
| 2 | SCHeLTI-LIFE TREE - Mothers Intervention - Preconception 6 months after enrolment |
|
2019 | 2022 | |
| 3 | SCHeLTI-LIFE TREE - Mothers Intervention - Preconception 9 months after enrolment |
|
2019 | 2022 | |
| 4 | SCHeLTI-LIFE TREE - Mothers Intervention - Preconception 12 months after enrolment |
|
2020 | 2023 | |
| 5 | SCHeLTI-LIFE TREE - Mothers Intervention - Pregnancy under 14 weeks |
|
|
2019 | 2022 |
| 6 | SCHeLTI-LIFE TREE - Mothers Intervention - Pregnancy 15 to 28 weeks |
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|
2019 | 2023 |
| 7 | SCHeLTI-LIFE TREE - Mothers Intervention - Pregnancy 29 to 36 weeks |
|
|
2019 | 2023 |
| 8 | SCHeLTI-LIFE TREE - Mothers Intervention - Delivery 0 to 7 days |
|
|
2019 | 2023 |
| 9 | SCHeLTI-LIFE TREE - Mothers Intervention - 6 weeks postpartum |
|
|
2019 | 2023 |
| 10 | SCHeLTI-LIFE TREE - Mothers Intervention - 3 months postpartum |
|
|
2020 | 2024 |
| 11 | SCHeLTI-LIFE TREE - Mothers Intervention - 6 months postpartum |
|
2020 | 2024 | |
| 12 | SCHeLTI-LIFE TREE - Mothers Intervention - 12 months postpartum |
|
|
2020 | 2024 |
| 13 | SCHeLTI-LIFE TREE - Mothers Intervention - 24 months postpartum |
|
2021 | 2025 | |
| 14 | SCHeLTI-LIFE TREE - Mothers Intervention - 36 months postpartum |
|
2022 | 2026 | |
| 15 | SCHeLTI-LIFE TREE - Mothers Intervention - 48 months postpartum |
|
2023 | 2027 | |
| 16 | SCHeLTI-LIFE TREE - Mothers Intervention - 60 months postpartum |
|
|
2024 | 2028 |
| 17 | SCHeLTI-LIFE TREE - Mothers Intervention - Additional data collections as needed |
|
2019 | 2028 |
SCHeLTI-LIFE TREE - Mothers - Control
The population is composed of women between 20 to 42 years of age who are: registered Shanghai residents, married to a registered Shanghai resident, or non-residents but have lived in Shanghai for at least 5 years, less than 14 weeks pregnant with one child, and planning to deliver in a participating study hospital. In the control group, participants receive usual prenatal and childhood care, but no study health promotion intervention.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
20
- Maximum age
-
42
- Pregnant Women
-
- First trimester
- Countries
-
- China
- Territory
- Shanghai
- Health Status
-
- Women are excluded from the study if they have HIV, Hepatitis B, Hepatitis C, major heart conditions, thalassemia major, cystic fibrosis, pre-existing type 1 diabetes mellitus, type 2 diabetes mellitus, or chronic medication-dependant hypertension.
- Other Criteria
- Participating women must be Mandarin speakers and less than 14 weeks pregnant. Women are excluded if they plan to move out participating Shanghai districts chosen for the study within five years, abuse drugs, or have multiple pregnancies.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from one of the 42 maternal child health units located within the four designated Shanghai districts.
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
- Supplementary information about number of participants
-
Nonpregnant women: 900 participants
Pregnant women (< 14 weeks): 1350 participants50% of 900 nonpregnant participants are expected to achieve a viable pregnancy within 1 year of enrolment and continue prenatal follow-up with the study.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SCHeLTI-LIFE TREE - Mothers Control - Preconception Baseline |
|
|
2019 | 2022 |
| 1 | SCHeLTI-LIFE TREE - Mothers Control - Preconception 3 months after enrolment |
|
2019 | 2022 | |
| 2 | SCHeLTI-LIFE TREE - Mothers Control - Preconception 6 months after enrolment |
|
2019 | 2022 | |
| 3 | SCHeLTI-LIFE TREE - Mothers Control - Preconception 9 months after enrolment |
|
2019 | 2022 | |
| 4 | SCHeLTI-LIFE TREE - Mothers Control - Preconception 12 months after enrolment |
|
2020 | 2023 | |
| 5 | SCHeLTI-LIFE TREE - Mothers Control - Pregnancy under 14 weeks |
|
|
2019 | 2022 |
| 6 | SCHeLTI-LIFE TREE - Mothers Control - Pregnancy 15 to 28 weeks |
|
|
2019 | 2023 |
| 7 | SCHeLTI-LIFE TREE - Mothers Control - Pregnancy 29 to 36 weeks |
|
|
2019 | 2023 |
| 8 | SCHeLTI-LIFE TREE - Mothers Control - Delivery 0 to 7 days |
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2019 | 2023 |
| 9 | SCHeLTI-LIFE TREE - Mothers Control - 6 weeks postpartum |
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2019 | 2023 |
| 10 | SCHeLTI-LIFE TREE - Mothers Control - 3 months postpartum |
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2020 | 2024 |
| 11 | SCHeLTI-LIFE TREE - Mothers Control - 6 months postpartum |
|
2020 | 2024 | |
| 12 | SCHeLTI-LIFE TREE - Mothers Control - 12 months postpartum |
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2020 | 2024 |
| 13 | SCHeLTI-LIFE TREE - Mothers Control - 24 months postpartum |
|
2021 | 2025 | |
| 14 | SCHeLTI-LIFE TREE - Mothers Control - 36 months postpartum |
|
2022 | 2026 | |
| 15 | SCHeLTI-LIFE TREE - Mothers Control - 48 months postpartum |
|
2023 | 2027 | |
| 16 | SCHeLTI-LIFE TREE - Mothers Control - 60 months postpartum |
|
|
2024 | 2028 |
| 17 | SCHeLTI-LIFE TREE - Mothers Control - Additional data collections as needed |
|
2019 | 2028 |
SCHeLTI-LIFE TREE - Fathers - Intervention
The population is composed of fathers or to be fathers of the child participants in the intervention group.
Selection Criteria
- Gender
-
Men only
- Countries
-
- China
- Territory
- Shanghai
Sources of Recruitment
- Specific Population
-
- Other specific population : Fathers of participating children.
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 1 | SCHeLTI-LIFE TREE - Fathers Intervention - Data collection |
|
|
2019 | 2028 |
SCHeLTI-LIFE TREE - Fathers - Control
The population is composed of fathers or to be fathers of the child participants in the control group.
Selection Criteria
- Gender
-
Men only
- Countries
-
- China
- Territory
- Shanghai
Sources of Recruitment
- Specific Population
-
- Other specific population : Fathers of participating children.
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 1 | SCHeLTI-LIFE TREE - Fathers Control - Data collection |
|
|
2019 | 2028 |
SCHeLTI-LIFE TREE - Children - Intervention
The population is composed of the children of participating mothers allocated to the intervention group of the study.
Selection Criteria
- Newborns
- Countries
-
- China
- Territory
- Shanghai
- Health Status
-
- Children are excluded if they have any major malformations in utero.
- Other Criteria
- Children born as a result of a multiple pregnancy are excluded.
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of participating mothers
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SCHeLTI-LIFE TREE - Children Intervention - Delivery 0 to 7 days |
|
|
2019 | 2023 |
| 1 | SCHeLTI-LIFE TREE - Children Intervention - 6 weeks postpartum |
|
|
2019 | 2023 |
| 2 | SCHeLTI-LIFE TREE - Children Intervention - 3 months postpartum |
|
|
2020 | 2024 |
| 3 | SCHeLTI-LIFE TREE - Children Intervention - 6 months postpartum |
|
|
2020 | 2024 |
| 4 | SCHeLTI-LIFE TREE - Children Intervention - 12 months postpartum |
|
|
2020 | 2024 |
| 5 | SCHeLTI-LIFE TREE - Children Intervention - 24 months postpartum |
|
|
2021 | 2025 |
| 6 | SCHeLTI-LIFE TREE - Children Intervention - 36 months postpartum |
|
2022 | 2026 | |
| 7 | SCHeLTI-LIFE TREE - Children Intervention - 48 months postpartum |
|
2023 | 2027 | |
| 8 | SCHeLTI-LIFE TREE - Children Intervention - 60 months postpartum |
|
|
2024 | 2028 |
| 9 | SCHeLTI-LIFE TREE - Children Intervention - Additional data collections as needed |
|
2019 | 2028 |
SCHeLTI-LIFE TREE - Children - Control
The population is composed of the children of participating mothers allocated to the control group of the study.
Selection Criteria
- Newborns
- Countries
-
- China
- Territory
- Shanghai
- Health Status
-
- Children are excluded if they have any major malformations in utero.
- Other Criteria
- Children born as a result of a multiple pregnancy are excluded.
Sources of Recruitment
- Specific Population
-
- Other specific population : Children of participating mothers
Sample Size
- Number of Participants
- 2,250
- Number of Participants with Biological Samples
- 2,250
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | SCHeLTI-LIFE TREE - Children Control - Delivery 0 to 7 days |
|
|
2019 | 2023 |
| 1 | SCHeLTI-LIFE TREE - Children Control - 6 weeks postpartum |
|
|
2019 | 2023 |
| 2 | SCHeLTI-LIFE TREE - Children Control - 3 months postpartum |
|
|
2020 | 2024 |
| 3 | SCHeLTI-LIFE TREE - Children Control - 6 months postpartum |
|
|
2020 | 2024 |
| 4 | SCHeLTI-LIFE TREE - Children Control - 12 months postpartum |
|
|
2020 | 2024 |
| 5 | SCHeLTI-LIFE TREE - Children Control - 24 months postpartum |
|
|
2021 | 2025 |
| 6 | SCHeLTI-LIFE TREE - Children Control - 36 months postpartum |
|
2022 | 2026 | |
| 7 | SCHeLTI-LIFE TREE - Children Control - 48 months postpartum |
|
2023 | 2027 | |
| 8 | SCHeLTI-LIFE TREE - Children Control - 60 months postpartum |
|
|
2024 | 2028 |
| 9 | SCHeLTI-LIFE TREE - Children Control - Additional data collections as needed |
|
2019 | 2028 |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-08-15T16:26:35.246