Exergame Study for Family Caregivers

Sponsor
Brandeis University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05032872
Collaborator
(none)
80
1
2
8.4
9.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social Exergame Treatment Group
  • Behavioral: Control Group
N/A

Detailed Description

The study is a 2-week baseline and 6-week intervention aimed at comparing the feasibility and efficacy of an exergame (Go&Grow without social contact components) and a social exergame (full version of Go&Grow) in promoting physical activity, social support, and well-being in family caregivers. The study also seeks to test social support and physical activity as mechanisms for the relationships between condition (exergame non-social vs social exergame) and wellbeing. Participants will be randomly assigned using a random assignment generator to either the control condition (exergame non-social) or the treatment condition (social exergame) on a rolling basis. Participants from both conditions will be reminded daily via app-based notifications during the intervention period to wear their Fitbit and to play the game.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Social Exergame Intervention to Promote Physical Activity, Social Support, And Well-Being in Family Caregivers
Actual Study Start Date :
Aug 16, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Social Exergame Treatment Group

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
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

Active Comparator: Control Group

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
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

Outcome Measures

Primary Outcome Measures

  1. Change in Physical Activity [Daily for 8 weeks]

    Daily step counts from the Fitbit step counter will be measured. A higher number indicates more daily steps.

  2. Change in Lubben Social Network Scale (LSNS) [Pretest (before week 1) and posttest (after week 8)]

    Self-report measure of social support from family and friends with scores ranging from 0-60 (Lubben & Gironda, 2014), with higher scores indicating higher social support.

  3. Change in Social Connectedness Scale [At the end of every week from week 1 to week 8]

    Social Connectedness Scale by van Bel et al (2009) assesses participants' relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity, and dissatisfaction with contact quantity and quality (scores range from 1 - 7 with higher scores indicating more social support (Bel et al., 2009).

  4. Change in UCLA Loneliness Scale [Pretest (before week 1) and posttest (after week 8), and at the end of every week from week 1 to week 8]

    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"). A higher score indicates more loneliness (Russell, 1996).

  5. Change in Positive and Negative Affect Schedule (PANAS) (20 items) [Pretest (before week 1) and posttest (after week 8), and at the end of every week from week 1 to week 8]

    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 (Total positive and negative affect scores can range from 10 - 50, with a higher score indicating a higher level of positive affect or negative affect) (Watson et al., 1988).

  6. Change in Perceived Stress Scale (PSS) [Pretest (before week 1) and posttest (after week 8)]

    Perceived Stress Scale (PSS) asks participants' stress perception over the last month (Possible scores will range from 0 to 40 with higher scores indicating higher stress) (Cohen et al., 1994).

  7. Change in Brief Symptom Inventory (BSI) [At the end of every week from week 1 to week 8]

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

Secondary Outcome Measures

  1. Change in Caregiver's Stress Scale (Pearlin et al., 1990) [Pretest (before week 1) and posttest (after week 8)]

    Caregiver's Stress Scale (Pearlin et al., 1990) has a series of 15 scales based on a conceptual model of caregivers' stress. Each scale ranges from 1 (strongly disagree) to 4 (strongly agree), and each scale will be averaged so that higher scores would indicate higher stress.

  2. Change in International Physical Activity Questionnaire (IPAQ) Short Version (Craig et al., 2003) [Pretest (before week 1) and posttest (after week 8)]

    International Physical Activity Questionnaire - Short Version (IPAQ-short; Craig et al., 2003). A continuous score will be 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 indicates higher level of physical activity.

  3. Change in Exercise Self-Efficacy by Neupert, Lachman, & Whitbourne (2009) [Pretest (before week 1) and posttest (after week 8)]

    9 items will be used to assess how certain participants will exercise under certain circumstances (e.g., when you are feeling under pressure or when you are away from home). Items are assessed from 1 (very sure) to 4 (not at all sure). A mean across all items will be calculated. A higher score indicates lower exercise self-efficacy.

  4. Change in Satisfaction with Life Scale (SWLS; Diener et al., 1985) [Pretest (before week 1) and posttest (after week 8)]

    Items are assessed from 1 (disagree strongly) to 7 (agree strongly). A mean across all items will be calculated. A higher score indicates a higher satisfaction with life.

  5. Change in Sense of Control (Lachman & Weaver, 1998) [Pretest (before week 1) and posttest (after week 8)]

    12 items will be used to assess sense of control. For example: "There is little I can do to change many of the important things in my life." Items are assessed from 1 (strongly disagree) to 7 (strongly agree). A mean across all items will be calculated. A higher score indicates a lower sense of control.

  6. Exergame Enjoyment Questionnaire (EEQ) [Posttest (after week 8)]

    Exergame Enjoyment Questionnaire (EEQ) will be included in the posttest, which measures how much participants enjoyed the exergame (Fitzgerald et al., 2020). 20 items ranged from strongly disagree (1) to strongly agree (5) will be summed with higher score indicating more exergame enjoyment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

  • 40 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

Exclusion Criteria:
  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brandeis University Waltham Massachusetts United States 02453

Sponsors and Collaborators

  • Brandeis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brandeis University
ClinicalTrials.gov Identifier:
NCT05032872
Other Study ID Numbers:
  • GoGrowExergrame #20104R
First Posted:
Sep 2, 2021
Last Update Posted:
Mar 10, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brandeis University

Study Results

No Results Posted as of Mar 10, 2022