NCT05032872

Brief Summary

The goal of this study is to examine Go\&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 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

August 16, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

August 24, 2021

Results QC Date

October 19, 2022

Last Update Submit

June 28, 2023

Conditions

Keywords

Family Caregivers

Outcome Measures

Primary Outcomes (9)

  • Percent Change in Steps

    Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step. Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps.

    Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8

  • Lubben Social Network Scale (LSNS)

    Self-report measure of social support from the Lubben Social Network Scale for family and friends with scores summed across 18 items. Possible scores range from 0-60, with higher scores indicating higher social support.

    Pretest (before week 1) and posttest (after week 8)

  • Social Connectedness Scale

    Social Connectedness Scale was administered weekly during the intervention with the following subscales: relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity and quality, and dissatisfaction with contact quantity. Scores were averaged across items from each subscale and possible scores ranged from 1 to 7 with higher scores indicating a higher level of the subscale.

    Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

  • UCLA Loneliness Scale

    The UCLA Loneliness Scale captures one's subjective feelings of loneliness over the past week for weekly surveys and over the past month for pretest and posttest surveys (20 items with ratings from 1 "Never" to 4 "Often"). The scores were averaged across the 20 items, with a score ranging from 1-4. A higher score indicates more loneliness.

    Pretest (before week 1) and posttest (after week 8)

  • Positive and Negative Affect Schedule (PANAS) (20 Items)

    Positive and Negative Affect Schedule (PANAS) (20 items) asks participants to report how often participants felt positive and negative feelings over the past week for weekly surveys, and over the past month for pre-test and post-test surveys. Scores were averaged across the items (Total positive and negative affect scores can range from 0-4, with a higher score indicating a higher level of positive affect or negative affect).

    Pretest (before week 1) and posttest (after week 8)

  • Perceived Stress Scale (PSS)

    Perceived Stress Scale (PSS) asks participants' stress perception over the last month and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).

    Pretest (before week 1) and posttest (after week 8)

  • Brief Symptom Inventory (BSI)

    Brief Symptom Inventory (BSI) captures participants' psychological distress over the past week, scores were summed across the items (Total score ranges from 0-72, with higher scores indicating more stress) (Derogatis, 1975).

    Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

  • Caregiver's Stress Scale

    Caregiver's Stress Scale has a series of subscales based on a conceptual model of caregivers' stress: overload, relational deprivation, job and caregiving conflict, role captivity, sense of self, caregiving competence, personal gain, management of situation, management of meaning, management of distress, and expressive support. Each subscale ranges from 1 (strongly disagree) to 4 (strongly agree), and each subscale was averaged (with possible score ranging from 1-4) so that higher scores would indicate a higher value.

    Pretest (before week 1) and posttest (after week 8)

  • International Physical Activity Questionnaire (IPAQ) Short Version

    International Physical Activity Questionnaire - Short Version. A continuous score was calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs\*min\*days) + (Mod METs\*min\*days) + Vig METs\*min\*days). A higher score means a higher level of physical activity.

    Pretest (before week 1) and posttest (after week 8)

Secondary Outcomes (4)

  • Exercise Self-Efficacy

    Pretest (before week 1) and posttest (after week 8)

  • Satisfaction With Life Scale

    Pretest (before week 1) and posttest (after week 8)

  • Sense of Control

    Pretest (before week 1) and posttest (after week 8)

  • Exergame Enjoyment Questionnaire (EEQ)

    Posttest (after week 8)

Study Arms (2)

Social Exergame Treatment Group

EXPERIMENTAL

The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.

Behavioral: Social Exergame Treatment Group

Control Group

ACTIVE COMPARATOR

The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.

Behavioral: Control Group

Interventions

* Physical activity tracking, walk to grow flowers and plant their own garden * Follow workout tutorials * Daily steps tracked by Fitbit and workout log tracked by the app * Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow * Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens * In-app rewards (unlock new flowers to grow each week) if participants post stories

Social Exergame Treatment Group
Control GroupBEHAVIORAL

* Physical activity tracking, walk to grow flowers and plant their own garden * Follow workout tutorials * Daily steps tracked by Fitbit and workout log tracked by the app * Daily reminders to wear Fitbit and use the app

Control Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are caregivers for a family member (e.g., relative, spouse, friend) who is 65 years or older and is either frail, has a disability, or has at least one chronic illness
  • years or older
  • Own an Android smartphone with Google play store/internet access
  • Able to walk for at least 20 minutes at a time
  • Comfortable wearing a fitness tracker for the duration of the study
  • Familiar with smartphone app usages
  • Comfortable with using the study-related app for the duration of the study

You may not qualify if:

  • Had a recent (within the past 6 months) cardiovascular event or fall.
  • Currently participating in any other physical activity study/intervention
  • Currently own or use a Fitbit or other activity tracking watches
  • Knows someone who is participating or has participated in the study
  • Currently physically active (exercise regularly 3 times a week or more for at least 30 minutes)
  • More than 2 errors on the Short Portable Mental Status Questionnaire (Pfeiffer, 1975).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandeis University

Waltham, Massachusetts, 02453, United States

Location

Related Publications (1)

  • Lin XY, Zhang L, Yoon S, Zhang R, Lachman ME. A Social Exergame Intervention to Promote Physical Activity, Social Support, and Well-Being in Family Caregivers. Gerontologist. 2023 Oct 17;63(9):1456-1466. doi: 10.1093/geront/gnad028.

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Xin Yao Lin
Organization
Brandeis University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 2, 2021

Study Start

August 16, 2021

Primary Completion

March 31, 2022

Study Completion

April 30, 2022

Last Updated

July 19, 2023

Results First Posted

July 19, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations