Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02715544
Other study ID # P&G 2015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date December 2020

Study information

Verified date August 2018
Source The University of Hong Kong
Contact Tanja Sobko, PhD
Phone +85251816160
Email tanja.sobko@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 6 Years
Eligibility 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 Design


Intervention

Other:
Healthy lifestyle
The families will receive a designed for these purposes intervention
physical activity and dietary guidelines
The families will receive a designed for these purposes intervention

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (10)

Barratt Hacking E, Barratt R, Scott W: Engaging children: research issues around participation and environmental learning. Environmental Education Research 2007, 13:529-544.

Bell JF, Wilson JS, Liu GC. Neighborhood greenness and 2-year changes in body mass index of children and youth. Am J Prev Med. 2008 Dec;35(6):547-53. doi: 10.1016/j.amepre.2008.07.006. — View Citation

Cleland V, Crawford D, Baur LA, Hume C, Timperio A, Salmon J. A prospective examination of children's time spent outdoors, objectively measured physical activity and overweight. Int J Obes (Lond). 2008 Nov;32(11):1685-93. doi: 10.1038/ijo.2008.171. Epub 2008 Oct 14. — View Citation

Cutter-Mackenzie A, Edwards S: Toward a Model for Early Childhood Environmental Education: Foregrounding, Developing, and Connecting Knowledge Through Play-Based Learning. The Journal of Environmental Education 2013, 44(3):195-213.

Dyment JE, Bell AC. Grounds for movement: green school grounds as sites for promoting physical activity. Health Educ Res. 2008 Dec;23(6):952-62. Epub 2007 Oct 22. — View Citation

Liefländer AK, Fröhlich G, Bogner FX, Schultz PW: Promoting connectedness with nature through environmental education. Environmental Education Research 2013, 19(3):370-384

Mullis F: Active parenting: an evaluation of two Adlerian parent education programs. Journal of Individual Psychology 1999, 55:225-232.

Nisbet EK, Zelenski JM. The NR-6: a new brief measure of nature relatedness. Front Psychol. 2013 Nov 1;4:813. doi: 10.3389/fpsyg.2013.00813. eCollection 2013. — View Citation

The Biophilia Hypothesis [http://books.google.com/books?hl=nl&lr=&id=qOg3-J0BoGoC&pgis=1]

Veselinovska SS, Osogovska TL: Engagement of Students in Environmental Activities in School. Procedia - Social and Behavioral Sciences 2012, 46:5015-5020.

Outcome

Type Measure Description Time frame Safety issue
Primary Eating habits A short validated Eating and Physical Activity Questionnaire (EPAQ) 3 years
Primary Physical activity Physical Activity Questionnaire for Preschool-aged Children (Pre-PAQ®) 3 years
Primary Nature relatedness a short, age-adjusted NRS scale 3 years
Secondary Parental knowledge of nutrition Nutrition Knowledge Questionnaire (NKQ) 3 years
Secondary Parental feeding behaviours The Preschool Child Feeding Questionnaire (PCFQ) 3 years
Secondary weight weight in kilograms 3 years
Secondary height height in meters 3 years
Secondary child neophobia Pliner's Child Neophobia Scale (PCNS) 3 years
See also
  Status Clinical Trial Phase
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Completed NCT02805478 - Fat-Associated Cardiovascular Organ Dysfunction
Active, not recruiting NCT02558920 - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Completed NCT03759743 - Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject N/A
Completed NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT03678766 - CHARGE: Controlling Hunger and ReGulating Eating N/A
Completed NCT04430465 - Effects of Wholegrains on Children's Health (KORN) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05376865 - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers N/A
Completed NCT03625427 - Effect of Palmitoleic Acid on C-reactive Protein N/A
Active, not recruiting NCT03435445 - Online Platform for Healthy Weight Loss (POEmaS) N/A
Enrolling by invitation NCT05576116 - Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Active, not recruiting NCT06023095 - A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities Phase 1
Completed NCT03648892 - Brain Dopamine Function in Human Obesity Early Phase 1
Not yet recruiting NCT05751993 - Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions N/A
Recruiting NCT02887950 - Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause N/A
Terminated NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4
Completed NCT03097237 - High Fiber Rye Foods for Weight and Body Fat Reduction N/A

External Links