Promoting Healthy Eating and Active Playtime by Connecting Preschool Children to Nature (Play&Grow)

August 23, 2018 updated by: Dr. Tanja Sobko, The University of Hong Kong
Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less active than is recommended and are increasingly engaged in sedentary behaviour, which places them at risk of becoming overweight or obese. The proposed project will test whether connecting families to nature positively influences physical activity (that is, active playtime) and healthy eating routines in children aged 2 to 4. The investigators have recently conducted a pilot study Play & Grow (P&G), a programme based on the most successful international preschool interventions described in the literature. In addition to adopting healthy eating and physical activity intervention elements, the programme was enhanced by including a novel third element: connectedness to nature (CN). To test the effectiveness of this enhanced intervention, the plan is to run a family-based randomised controlled trial (RCT). The intervention will include 240 families with children aged 2 to 4, will take the form of one-hour activity sessions for parents and children held once a week for 10 weeks. The investigators will assess lifestyle-related habits before, immediately after the completion the intervention, at 6 months and one year after the intervention. Created for this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are intended to be used to understand which components of the intervention were most effective. The objectives of this project will be achieved over a 36-month period, and it is expected to contribute to a close examination of key components of successful healthy lifestyle promotion programme during early childhood. The investigators predict that is that the new element CN will significantly improve the intervention. Finally, the overall aim is that connecting families to nature will result in sustainable lifestyle changes that remain with them for a lifetime.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Proper nutrition and physical activity are essential for a healthy life. Time spent in nature has also been proven beneficial. Systematic reviews have shown that nature-related activities enhance general well-being as reflected in increased physical activity, a healthier diet, reduced stress and better sleep. However, existing programmes promoting healthy lifestyles in children focus almost exclusively on diet and physical activity. None, to the inestigators's awareness, taken into consideration interactions, or connectedness with nature. Connectedness to nature/nature relatedness is a relatively new concept that, to date, has been investigated primarily in adults.The concept suggests, for example, that engaging in activities in a natural environment can induce a feeling of connectedness to nature. Exposing preschool children to nature and to thinking about nature in different ways could stimulate nature relatedness as a measurable construct. When children are placed in a natural setting, they are more likely to be physically active. Natuxral products such as fruits and vegetables are widely acknowledged to improve health. As noted above, parents are children's role models, and the investigators therefore believe that connecting parents with nature will have benefits for their children. Many habits and attitudes are developed early in life, and those related to the natural world are no exception. In fact, children are inherently interested in their environment and in nature in general. The hypothesis is that both indoor and outdoor nature-related activities may induce connectedness and bring about positive changes in both eating and activity habits (short-term outcomes) in preschool children, in turn leading to a healthier lifestyle (long-term outcomes).The aim of P&G is to encourage healthy eating habits and active play in children from an early age, and to bring about healthy behavioural changes in families. The programme also includes a CN element designed to equip parents with environmental knowledge and skills. The generated re- and post-test comparison data indicated the effectiveness of the programme (not presented here). A detailed manual and full resource kit were created, and each session consisted of: (i) a 15-minute theoretical education component (food, activity, CN), and (ii) a 30-minute component on indoor and outdoor nature-related activities, such as playing with nature objects and searching for natural treasures. Some nature activities were food-related (e.g. growing plants, creating miniature indoor gardens, and healthy cooking). The control group received an information folder containing government-recommended physical activity and dietary guidelines for children. To enhance participation, the sessions were scheduled for weekends. The outcome data was collected using a number of scales and questionnaires addressed eating, active play and nature-related habits before and after the program, and focus group discussions were held at the beginning and end of the programme. The programme proved popular amongst participants and the results demonstrated significant positive changes on number of health-related outcomes, such as food habits and caregiver physical activity levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000
        • Recruiting
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2-4 year old children
  • With English-speaking parents

Exclusion Criteria:

  • Children with chronic health conditions
  • Families who have recently taken part in a healthy lifestyle promotion programme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
The group will receive healthy lifestyle intervention
Other: Healthy lifestyle
The families will receive a designed for these purposes intervention
Active Comparator: control group
Other: physical activity and dietary guidelines
Other: physical activity and dietary guidelines
The families will receive a designed for these purposes intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eating habits
Time Frame: 3 years
A short validated Eating and Physical Activity Questionnaire (EPAQ)
3 years
Physical activity
Time Frame: 3 years
Physical Activity Questionnaire for Preschool-aged Children (Pre-PAQ®)
3 years
Nature relatedness
Time Frame: 3 years
a short, age-adjusted NRS scale
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental knowledge of nutrition
Time Frame: 3 years
Nutrition Knowledge Questionnaire (NKQ)
3 years
Parental feeding behaviours
Time Frame: 3 years
The Preschool Child Feeding Questionnaire (PCFQ)
3 years
weight
Time Frame: 3 years
weight in kilograms
3 years
height
Time Frame: 3 years
height in meters
3 years
child neophobia
Time Frame: 3 years
Pliner's Child Neophobia Scale (PCNS)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanja sobko, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P&G 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hong Kong Ethics Committee

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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