Trial Outcomes & Findings for Cell Phone Intervention in Young Adults (NCT NCT01092364)
NCT ID: NCT01092364
Last Updated: 2017-11-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
365 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2017-11-13
Participant Flow
Participant milestones
| Measure |
Cell Phone Intervention
Behavioral lifestyle intervention for weight loss, delivered by cell phone.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Personal Counseling Intervention
Behavioral lifestyle intervention for weight loss, delivered by personal counseling.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Advice Only
Advice only control group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
120
|
123
|
|
Overall Study
COMPLETED
|
104
|
104
|
105
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Waist circumference is presented by gender.
Baseline characteristics by cohort
| Measure |
Cell Phone Intervention
n=122 Participants
Behavioral lifestyle intervention for weight loss, delivered by cell phone.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Personal Counseling Intervention
n=120 Participants
Behavioral lifestyle intervention for weight loss, delivered by personal counseling.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Advice Only
n=123 Participants
Advice only control group.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=122 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=365 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=122 Participants
|
120 Participants
n=120 Participants
|
123 Participants
n=123 Participants
|
365 Participants
n=365 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=122 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=365 Participants
|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 4.2 • n=122 Participants
|
29.4 years
STANDARD_DEVIATION 4.3 • n=120 Participants
|
29.6 years
STANDARD_DEVIATION 4.3 • n=123 Participants
|
29.4 years
STANDARD_DEVIATION 4.3 • n=365 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=122 Participants
|
85 Participants
n=120 Participants
|
85 Participants
n=123 Participants
|
254 Participants
n=365 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=122 Participants
|
35 Participants
n=120 Participants
|
38 Participants
n=123 Participants
|
111 Participants
n=365 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=122 Participants
|
7 Participants
n=120 Participants
|
5 Participants
n=123 Participants
|
21 Participants
n=365 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=122 Participants
|
113 Participants
n=120 Participants
|
118 Participants
n=123 Participants
|
344 Participants
n=365 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=365 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=122 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=365 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=122 Participants
|
2 Participants
n=120 Participants
|
5 Participants
n=123 Participants
|
12 Participants
n=365 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=122 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=365 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=122 Participants
|
48 Participants
n=120 Participants
|
42 Participants
n=123 Participants
|
132 Participants
n=365 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=122 Participants
|
65 Participants
n=120 Participants
|
70 Participants
n=123 Participants
|
203 Participants
n=365 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=122 Participants
|
3 Participants
n=120 Participants
|
3 Participants
n=123 Participants
|
6 Participants
n=365 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=122 Participants
|
1 Participants
n=120 Participants
|
3 Participants
n=123 Participants
|
10 Participants
n=365 Participants
|
|
Region of Enrollment
United States
|
122 Participants
n=122 Participants
|
120 Participants
n=120 Participants
|
123 Participants
n=123 Participants
|
365 Participants
n=365 Participants
|
|
Weight
|
102.4 kg
STANDARD_DEVIATION 25.2 • n=122 Participants
|
99.3 kg
STANDARD_DEVIATION 23.4 • n=120 Participants
|
101.3 kg
STANDARD_DEVIATION 22.6 • n=123 Participants
|
101.0 kg
STANDARD_DEVIATION 23.7 • n=365 Participants
|
|
BMI
|
35.7 Kg/m^2
STANDARD_DEVIATION 8.2 • n=122 Participants
|
34.9 Kg/m^2
STANDARD_DEVIATION 7.5 • n=120 Participants
|
35.1 Kg/m^2
STANDARD_DEVIATION 7.5 • n=123 Participants
|
35.2 Kg/m^2
STANDARD_DEVIATION 7.8 • n=365 Participants
|
|
Waist Circumference
Males
|
113.8 cm
STANDARD_DEVIATION 17.9 • n=38 Participants • Waist circumference is presented by gender.
|
111.5 cm
STANDARD_DEVIATION 16.4 • n=35 Participants • Waist circumference is presented by gender.
|
109.8 cm
STANDARD_DEVIATION 14.6 • n=38 Participants • Waist circumference is presented by gender.
|
111.7 cm
STANDARD_DEVIATION 16.3 • n=111 Participants • Waist circumference is presented by gender.
|
|
Waist Circumference
Females
|
109.3 cm
STANDARD_DEVIATION 18.4 • n=84 Participants • Waist circumference is presented by gender.
|
107.4 cm
STANDARD_DEVIATION 16.4 • n=85 Participants • Waist circumference is presented by gender.
|
107.9 cm
STANDARD_DEVIATION 15.7 • n=85 Participants • Waist circumference is presented by gender.
|
108.2 cm
STANDARD_DEVIATION 16.8 • n=254 Participants • Waist circumference is presented by gender.
|
|
Dietary intake
|
51.6 Scores on the HEI scale
STANDARD_DEVIATION 4.2 • n=122 Participants
|
50.8 Scores on the HEI scale
STANDARD_DEVIATION 3.6 • n=120 Participants
|
50.7 Scores on the HEI scale
STANDARD_DEVIATION 4.4 • n=123 Participants
|
51.0 Scores on the HEI scale
STANDARD_DEVIATION 4.1 • n=365 Participants
|
|
Physical activity
|
756.0 kcal/week
STANDARD_DEVIATION 846.1 • n=122 Participants
|
1009.3 kcal/week
STANDARD_DEVIATION 1346.4 • n=120 Participants
|
865.9 kcal/week
STANDARD_DEVIATION 1133.9 • n=123 Participants
|
879.7 kcal/week
STANDARD_DEVIATION 1134.2 • n=365 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Intention to treat
Outcome measures
| Measure |
Cell Phone Intervention
n=122 Participants
Behavioral lifestyle intervention for weight loss, delivered by cell phone.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Personal Counseling Intervention
n=120 Participants
Behavioral lifestyle intervention for weight loss, delivered by personal counseling.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Advice Only
n=123 Participants
Advice only control group.
|
|---|---|---|---|
|
Change in Body Weight
|
-0.99 kg
Standard Deviation 6.2
|
-2.6 kg
Standard Deviation 6.0
|
-1.7 kg
Standard Deviation 8.3
|
Adverse Events
Cell Phone Intervention
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Personal Counseling Intervention
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Advice Only
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cell Phone Intervention
n=122 participants at risk
Behavioral lifestyle intervention for weight loss, delivered by cell phone.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Personal Counseling Intervention
n=120 participants at risk
Behavioral lifestyle intervention for weight loss, delivered by personal counseling.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Advice Only
n=123 participants at risk
Advice only control group.
|
|---|---|---|---|
|
Gastrointestinal disorders
Cholecystectomy
|
0.00%
0/122 • 24 months
|
0.83%
1/120 • Number of events 1 • 24 months
|
0.00%
0/123 • 24 months
|
|
Psychiatric disorders
Psychiatric hospitalization
|
0.00%
0/122 • 24 months
|
0.00%
0/120 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Obstetric hospitalization
|
0.00%
0/122 • 24 months
|
0.00%
0/120 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
|
General disorders
Other
|
3.3%
4/122 • Number of events 4 • 24 months
|
2.5%
3/120 • Number of events 3 • 24 months
|
1.6%
2/123 • Number of events 2 • 24 months
|
Other adverse events
| Measure |
Cell Phone Intervention
n=122 participants at risk
Behavioral lifestyle intervention for weight loss, delivered by cell phone.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Personal Counseling Intervention
n=120 participants at risk
Behavioral lifestyle intervention for weight loss, delivered by personal counseling.
Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
|
Advice Only
n=123 participants at risk
Advice only control group.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal injury
|
6.6%
8/122 • Number of events 8 • 24 months
|
3.3%
4/120 • Number of events 4 • 24 months
|
0.81%
1/123 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place