Trial Outcomes & Findings for Engaging Rural Men With Mobile Technologies for Weight Loss (NCT NCT03329079)
NCT ID: NCT03329079
Last Updated: 2023-10-04
Results Overview
Weight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Observed means from baseline weight and at 6 months
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Mobile Technology Plus (MT+)
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Engaging Rural Men With Mobile Technologies for Weight Loss
Baseline characteristics by cohort
| Measure |
Mobile Technology Plus (MT+)
n=40 Participants
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
n=40 Participants
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.06 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
54.35 years
STANDARD_DEVIATION 9.10 • n=7 Participants
|
54.20 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Observed means from baseline weight and at 6 monthsWeight in kilograms (as measured on a Tanita brand digital scale, TBF-215 Tanita Corporation of America)
Outcome measures
| Measure |
Mobile Technology Plus (MT+)
n=36 Participants
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
n=38 Participants
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
|---|---|---|
|
Mean Change in Weight by Randomized Group
|
-7.03 kilograms
Standard Deviation 2.9
|
-4.14 kilograms
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: Observed means from baseline fruit and vegetable intake at 6 monthsdaily fruit and vegetable servings (Brief Risk Factor Surveillance Survey written questionnaire- Fruit and vegetable dietary intake module (Reported total number of fruit and vegetable serving sizes per 24 hour period)
Outcome measures
| Measure |
Mobile Technology Plus (MT+)
n=36 Participants
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
n=37 Participants
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
|---|---|---|
|
Point Estimate and Variability of Outcome Measure for Fruit and Vegetable Intake
|
3.16 servings per day
Standard Deviation 1.67
|
3.09 servings per day
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Observed means from baseline beverage intake and at 6 monthssugar-sweetened total beverage energy intake (Sugar Sweetened beverage intake questionnaire (BEV-Q15) Reported total number of fluid ounces consumed per 24 hour period)
Outcome measures
| Measure |
Mobile Technology Plus (MT+)
n=36 Participants
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
n=38 Participants
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
|---|---|---|
|
Point Estimate and Variability of Outcome Measure for Beverage Intake Quality
|
4.34 fluid ounces per day
Standard Deviation 6.44
|
10.58 fluid ounces per day
Standard Deviation 17.01
|
SECONDARY outcome
Timeframe: Observed means from baseline overall physical activity and at 6 monthstotal steps taken in 24 hour period (Automated app report of total steps measured via gyroscope on smart phone- total step count range 0-10,000 steps (higher step value represents desired outcome of 10,000 steps per day)
Outcome measures
| Measure |
Mobile Technology Plus (MT+)
n=28 Participants
Experimental arm will receive a 3-month MT+ intervention using the premium mobile phone app version with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
Mobile Technology Plus: The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
|
Mobile Technology (MT)
n=25 Participants
Comparison group will receive the basic version of the mobile phone app only.
Mobile Technology: The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
|
|---|---|---|
|
Point Estimate and Variability of Outcome Measure for Physical Activity
|
6874.64 Activity steps as measured by phone app
Standard Deviation 4650.58
|
5359.50 Activity steps as measured by phone app
Standard Deviation 2995.44
|
Adverse Events
Mobile Technology Plus (MT+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile Technology (MT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place