Exergame Study for Family Caregivers

Not Applicable

Completed

Conditions: Sedentary Lifestyle

Interventions: Behavioral: Social Exergame Treatment Group
Behavioral: Control Group

Registration Number: NCT05032872

Lead Sponsor: Brandeis University

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Exergame Treatment Group	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.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
Social Connectedness Scale	Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8	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.
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 and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).
Brief Symptom Inventory (BSI)	Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8	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).
Caregiver's Stress Scale	Pretest (before week 1) and posttest (after week 8)	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.
International Physical Activity Questionnaire (IPAQ) Short Version	Pretest (before week 1) and posttest (after week 8)	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.
Percent Change in Steps	Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8	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.
Lubben Social Network Scale (LSNS)	Pretest (before week 1) and posttest (after week 8)	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.
UCLA Loneliness Scale	Pretest (before week 1) and posttest (after 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"). The scores were averaged across the 20 items, with a score ranging from 1-4. A higher score indicates more loneliness.
Positive and Negative Affect Schedule (PANAS) (20 Items)	Pretest (before week 1) and posttest (after 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. 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).

Secondary Outcome Measures

Name	Time	Method
Sense of Control	Pretest (before week 1) and posttest (after week 8)	items were 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) and reverse coded. A sum across all items was calculated ranging from 6-42. A higher score indicates a higher sense of control.
Exergame Enjoyment Questionnaire (EEQ)	Posttest (after week 8)	Exergame Enjoyment Questionnaire (EEQ) was included in the posttest, which measured how much participants enjoyed the exergame (Fitzgerald et al., 2020). 20 items ranged from strongly disagree (1) to strongly agree (5) were summed. Scores rannged from 20 - 100, with a higher score indicating more exergame enjoyment.
Satisfaction With Life Scale	Pretest (before week 1) and posttest (after week 8)	Items are assessed from 1 (disagree strongly) to 7 (agree strongly) summed across all items, ranging from 5-35. A higher score indicates a higher satisfaction with life.
Exercise Self-Efficacy	Pretest (before week 1) and posttest (after week 8)	9 items assessed 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). Items were reverse coded and summed across all items with a score ranging from 9 to 36. A higher score indicates higher exercise self-efficacy.