Trial Outcomes & Findings for Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors (NCT NCT01472276)
NCT ID: NCT01472276
Last Updated: 2023-05-01
Results Overview
Between-group change in weight loss at 3-month follow-up
COMPLETED
PHASE2
65 participants
3 months
2023-05-01
Participant Flow
Participant milestones
| Measure |
Control
|
Web-based Program
Web-based program: Provided with the web-based program
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
3-month Follow-up
|
32
|
25
|
|
Overall Study
6-month Follow-up
|
31
|
21
|
|
Overall Study
COMPLETED
|
29
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors
Baseline characteristics by cohort
| Measure |
Control
n=33 Participants
|
Web-based Program
n=32 Participants
Web-based program: Provided with the web-based program
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 7.27 • n=99 Participants
|
51.4 years
STANDARD_DEVIATION 7.59 • n=107 Participants
|
52.1 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Weight (kg) outcome differences within study groups from baseline to 3 months (complete-case analysis).
Between-group change in weight loss at 3-month follow-up
Outcome measures
| Measure |
Control
n=32 Participants
|
Web-based Program
n=25 Participants
Web-based program: Provided with the web-based program
|
|---|---|---|
|
Weight Loss Kg
|
-0.53 kg
Interval -1.6 to 0.54
|
-4.37 kg
Interval -5.8 to -2.94
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsBetween-group change in weight loss at 6 and 12 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsAssessed by triaxial accelerometer and RPAQ questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsSeated, systolic and diastolic mmHg
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsTotal cholesterol HDL cholesterol, LDL cholesterol, triglycerides high-sensitivity CRP, HOMA, HbA1c
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsDiet history
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsSpygmoCor Pulse Wave Analysis System
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsQuestionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsQuestionnaire
Outcome measures
Outcome data not reported
Adverse Events
Control
Web-based Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michelle McKinley, Professor
Queen's University, Belfast
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place