Trial Outcomes & Findings for Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults (NCT NCT01803737)
NCT ID: NCT01803737
Last Updated: 2014-02-17
Results Overview
Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Week 0 and 12
Results posted on
2014-02-17
Participant Flow
We recruited twenty six (N=26) sedentary, overweight and obese adult men and women to participate in a behavioral weight loss intervention at the University of Pittsburgh Physical Activity and Weight Management Research Center. Recruitment occurred between January 2013 and March 2013.
Participant milestones
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Overall Study
Lack of Time
|
1
|
0
|
|
Overall Study
Medical Reason
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
Baseline characteristics by cohort
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 and 12Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Body Weight
|
-5.6 kg
Standard Deviation 2.9
|
-3.1 kg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Week 0 and 12A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Physical Activity
|
983.3 kcals/wk
Standard Deviation 567.6
|
776.3 kcals/wk
Standard Deviation 1194.8
|
SECONDARY outcome
Timeframe: Week 0 and 12A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Dietary Intake: Kcals/Day
|
474.8 kcals/day
Standard Deviation 509
|
242.5 kcals/day
Standard Deviation 709.3
|
SECONDARY outcome
Timeframe: Week 0 and 12A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Dietary Intake: % Fat
|
-3.26 percentage of fat intake
Standard Deviation 5.58
|
-0.00 percentage of fat intake
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: Week 0 and 12A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Dietary Intake: % Protein
|
0.73 percentage of protein intake
Standard Deviation 2.38
|
0.44 percentage of protein intake
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: Week 0 and 12A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Dietary Intake: % Carbohydrate
|
0.64 percentage of carbohydrate intake
Standard Deviation 6.15
|
0.90 percentage of carbohydrate intake
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Week 0 and 12The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=143 Eating and Exercise Diary
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=143 Eating and Exercise Diary
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Completion of Self-monitoring of Dietary Intake and Physical Activity
|
91.6 percentage of diaries completed
Standard Deviation 18
|
60.1 percentage of diaries completed
Standard Deviation 38.5
|
SECONDARY outcome
Timeframe: Week 0 and 12Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=13 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=13 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Change in Weight Loss Self-efficacy
|
28.3 units on a scale
Standard Deviation 35.7
|
16.3 units on a scale
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: Week 12At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants' reasons for continuing participation in a weight loss program via participants' endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.
Outcome measures
| Measure |
Standard Behavioral Weight Loss Intervention (SBWL)
n=12 Participants
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
|
Campaign Intervention (CI)
n=10 Participants
Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
|
|---|---|---|
|
Autonomous and Controlled Motivation
Autonomous Motivation
|
6.3 units on a scale
Standard Deviation 0.9
|
5.3 units on a scale
Standard Deviation 1.5
|
|
Autonomous and Controlled Motivation
Controlled Motivation
|
2.9 units on a scale
Standard Deviation 1.1
|
2.9 units on a scale
Standard Deviation 1.0
|
Adverse Events
Standard Behavioral Weight Loss Intervention (SBWL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Campaign Intervention (CI)
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