NCT04902014

A Study to Test the Effectiveness of Different Interventions to Improve Physical Activity in Adults.

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Motivational Interviewing in Healthy in 40 participants. Completed in 21 September 2020.

Timeline

13 April 2020

Primary endpoint
21 September 2020

21 September 2020

Quick facts

Lead sponsor	Colorado State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	13 April 2020
Primary completion	21 September 2020
Estimated completion	21 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing
• Education
• Wearable Fitness Trackers
• Wearable Fitness Tracker+

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Colorado State University

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Motivation From Baseline at 12 Weeks. Primary · Baseline and at 12 weeks.

Changes in motivation for physical activity as described by the self-determination theory was assessed using the Behavioral Regulation in Exercise Questionnaire, v3 (BREQ-3) and the Basic Psychological Needs in Exercise Scale (BPNS). The BREQ-3 uses four survey items per motivational subtype (Amotivation, External, Introjected, Identified, and Integrated Regulation, and Intrinsic Motivation). The BPNS uses three of four items per psychological need (Autonomy, Competence, and Relatedness) The raw scores per subtype or need are averaged for one subtype and need score per participant. The scale r

Amotivation

Group	Value	95% CI
Education	0.30	± 0.40
Motivational Interviewing	0.48	± 0.43
Wearable Fitness Tracker	0.40	± 0.36
Wearable Fitness Tracker+	0.43	± 0.49

External Regulation

Group	Value	95% CI
Education	1.58	± 1.25
Motivational Interviewing	1.45	± 0.91
Wearable Fitness Tracker	0.89	± 0.40
Wearable Fitness Tracker+	1.27	± 0.73

Introjected Regulation

Group	Value	95% CI
Education	2.45	± 1.02
Motivational Interviewing	2.33	± 0.82
Wearable Fitness Tracker	2.31	± 0.77
Wearable Fitness Tracker+	2.48	± 0.63

Identified Regulation

Group	Value	95% CI
Education	3.10	± 0.47
Motivational Interviewing	3.10	± 0.53
Wearable Fitness Tracker	3.20	± 0.75
Wearable Fitness Tracker+	3.33	± 0.54

Integrated Regulation

Group	Value	95% CI
Education	2.38	± 0.93
Motivational Interviewing	2.45	± 0.47
Wearable Fitness Tracker	2.61	± 0.81
Wearable Fitness Tracker+	2.63	± 0.83

Intrinsic Motivation

Group	Value	95% CI
Education	2.47	± 0.53
Motivational Interviewing	2.70	± 0.62
Wearable Fitness Tracker	2.87	± 0.80
Wearable Fitness Tracker+	2.98	± 0.59

Relative Autonomy Index

Group	Value	95% CI
Education	3.37	± 2.59
Motivational Interviewing	4.00	± 2.06
Wearable Fitness Tracker	5.08	± 2.27
Wearable Fitness Tracker+	4.78	± 2.22

Autonomy

Group	Value	95% CI
Education	3.62	± 0.72
Motivational Interviewing	3.97	± 0.43
Wearable Fitness Tracker	4.10	± 0.45
Wearable Fitness Tracker+	4.23	± 0.35

Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks. Primary · Baseline and at 12 weeks

Moderate to Vigorous Physical Activity (MVPA) was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).

Minutes of Moderate to Vigorous Physical Activity per Day

Group	Value	95% CI
Education	66.70	± 17.83
Motivational Interviewing	67.75	± 16.47
Wearable Fitness Tracker	76.37	± 29.19
Wearable Fitness Tracker+	71.08	± 36.90

Minutes of Moderate to Vigorous Physical Activity per Weekday

Group	Value	95% CI
Education	66.17	± 16.99
Motivational Interviewing	64.00	± 25.10
Wearable Fitness Tracker	78.97	± 32.67
Wearable Fitness Tracker+	68.60	± 41.11

Minutes of Moderate to Vigorous Activity per Weekend Day

Group	Value	95% CI
Education	72.32	± 29.27
Motivational Interviewing	69.70	± 22.30
Wearable Fitness Tracker	66.17	± 38.62
Wearable Fitness Tracker+	76.38	± 38.50

Change in Steps Per Day From Baseline at 12 Weeks. Primary · Baseline and at 12 weeks

Steps per day was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).

Steps per Day

Group	Value	95% CI
Education	6155.58	± 1370.35
Motivational Interviewing	5400.56	± 1314.90
Wearable Fitness Tracker	6693.01	± 2394.24
Wearable Fitness Tracker+	6232.15	± 2857.27

Steps per Weekday

Group	Value	95% CI
Education	6216.31	± 1370.35
Motivational Interviewing	5211.16	± 1847.80
Wearable Fitness Tracker	7183.81	± 2430.83
Wearable Fitness Tracker+	6123.24	± 3047.30

Steps per Weekend Day

Group	Value	95% CI
Education	6387.75	± 2350.78
Motivational Interviewing	5235.22	± 1749.21
Wearable Fitness Tracker	5275.90	± 3292.88
Wearable Fitness Tracker+	6565.06	± 3156.44

Sponsor's own description

During the initial months of the COVID-19 pandemic, physical activity (PA) engagement levels declined worldwide. Despite the overwhelming adoption of wearable fitness tracker (WFT) devices, it continues to be unclear as to their effect on PA engagement or PA motivation. Building on past research, we hypothesized that combining a WFT with a known impactful intervention, motivational interviewing (MI) would positively influence both self-determination theory (SDT) motivation and PA during an unprecedented global emergency.

A four-group randomized controlled study was conducted amongst 40 inactive adults over a 12-week period during the COVID-19 pandemic. One group (WFT, n = 10) received a wearable fitness tracker, a second (MI, n=10) received bi-weekly MI sessions, a third (WFT+, n=10) received both, and a fourth (Education, n=10) received basic PA education. Outcome measures for motivation and PA were measured though an online survey before and after the 12-week period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.