NCT02601534

Brief Summary

The goal of the study is to evaluate the effectiveness of a family-focused, interactive, and theory-based intervention to reduce the sedentary behavior and increase physical activity, family communication and well-being of the participants. The intervention is to use Zero-time Exercise, the positive psychology theme "Appreciation and Gratitude" \[23, 24\], and role modelling approach to get sedentary people to start exercising, increase levels of physical activity, family communication and well-being of the participants and their family members. The intervention aims to encourage positive and sustainable health actions among participants and their family members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
673

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

November 5, 2015

Last Update Submit

July 10, 2018

Conditions

Keywords

sedentary behaviourphysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises

    Behaviors on performing physical activity will be assessed by outcome-based questionnaire

    baseline, 3 months

Secondary Outcomes (8)

  • Change in behavior on performing physical activity in relation to Zero-time Exercise, moderate and vigorous exercises

    baseline, 3 months, 6 months, 1 year

  • Change in behavior on taking healthy diet

    baseline, 3 months, 6 months, 1 year

  • Attitude on performing Zero-time Exercise,

    immediate after training session, 3 months, 6 months, 1 year

  • Perceived ability and intention to motivate participants themselves and their family to increase Zero-time Exercise

    baseline, 3 months, 6 months, 1 year

  • Change in participants' own health and happiness

    baseline, 3 months, 6 months, 1 year

  • +3 more secondary outcomes

Study Arms (2)

Zero-time Exercise (PA) group

EXPERIMENTAL

The intervention arm (PA group) aims to improve family communication and well-being, reduce sedentary behavior and increase physical activity. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages. The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve dietary habits.

Behavioral: Zero-time Exercise

Healthy Eating (HE) group

PLACEBO COMPARATOR

The control arm (HE group) aims to improve family communication and well-being and enhance healthy eating habits. Participants are required to engage their family members in their activities. The programme includes a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months after the first session as well as biweekly/monthly mobile messages. The holistic health session is not a part of the cRCT, it aims to collect one-year feedback from participants and provides additional health information to improve physical activity habit.

Behavioral: Healthy Eating

Interventions

a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve physical activity habit.

Zero-time Exercise (PA) group
Healthy EatingBEHAVIORAL

a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve dietary habit.

Healthy Eating (HE) group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with at least on child between 3 and 18;
  • Parents with at least primary school educational level:
  • Parents who can read and write Chinese.

You may not qualify if:

  • People with a serious health condition that might prevent them from participating in physical activity;
  • Parents who do not have a child between 3 and 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caritas integrated Family Service Centre

Hong Kong, 852, Hong Kong

Location

Related Publications (1)

  • Lai AYK, Lam EYW, Fabrizo C, Lee DPK, Wan ANT, Tsang JSY, Ho LM, Stewart SM, Lam TH. A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial. Front Public Health. 2020 Sep 15;8:434. doi: 10.3389/fpubh.2020.00434. eCollection 2020.

Related Links

MeSH Terms

Conditions

HypokinesiaMotor Activity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Agnes YK Lai, DN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager (Health Communication)

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 10, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations