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The purpose of this study is to examine the feasibility of a campaign intervention for weight management compared to a standard behavioral weight loss intervention in overweight and obese adults.
The feasibility of solely using a campaign intervention (CI) to promote healthy eating and physical activity behaviors for weight loss and weight maintenance has not been examined in a systematic manner. Thus, the primary aim of this study will be to examine whether a stand-alone CI results in similar weight loss compared to a standard behavioral weight loss intervention (SBWL). It is hypothesized that the CI will achieve a similar weight loss when compared to the SBWL. Additional aims include the examination of the CI on changes in moderate to vigorous intensity physical activity, dietary intake, self-monitoring of dietary intake and physical activity, weight loss self-efficacy, and motivation compared to a SBWL. This study will recruit forty-eight 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 (PAWMRC). To be considered eligible for this study, participants must be 18-55 years of age, with a Body Mass Index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m². Assessments will be conducted at week 0 and 12 of the intervention. Each assessment will take approximately 30 minutes to complete and include height, body weight, and assessment of physical activity, dietary intake, weight loss self-efficacy, and motivation. Upon successful completion of baseline assessments, eligible subjects will be randomly assigned to one of two groups using a stratified randomized block design: 1) standard behavioral weight loss intervention (SBWL) or 2) campaign intervention (CI). The CI will target specific diet and physical activity behaviors to improve weight loss efforts within a thematic framework based on the professional auto racing point system concept. CI session content and targeted behavior goals will tie into this overall theme and throughout the campaign participants will have the opportunity to earn incentives to reinforce positive behavior changes. This study is a necessary first step to examine the feasibility of a stand-alone campaign as an alternative strategy for weight management when compared to a standard behavioral weight loss intervention. Furthermore, this study will provide variance estimates on the effectiveness of a campaign intervention compared to a standard behavioral weight loss program that can be used to determine appropriate sample sizes for a future full-scale clinical study of this alternative strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Active Comparator | Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. |
|
| Campaign Intervention (CI) | Experimental | Included 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Behavioral | Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period. | Week 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | A questionnaire will be used to measure and quantify energy expenditure from physical activity. | Week 0 and 12 |
| Change in Dietary Intake: Kcals/Day | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O Garcia, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania | 15217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22253363 | Background | Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17. | |
| 22822174 | Background | Cohen SS, Signorello LB, Cope EL, McLaughlin JK, Hargreaves MK, Zheng W, Blot WJ. Obesity and all-cause mortality among black adults and white adults. Am J Epidemiol. 2012 Sep 1;176(5):431-42. doi: 10.1093/aje/kws032. Epub 2012 Jul 20. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Behavioral Weight Loss Intervention (SBWL) | Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. |
| FG001 | Campaign Intervention (CI) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Campaign Intervention (CI) | Behavioral | Included 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. |
|
| Week 0 and 12 |
| Change in Dietary Intake: % Fat | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Week 0 and 12 |
| Change in Dietary Intake: % Protein | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Week 0 and 12 |
| Change in Dietary Intake: % Carbohydrate | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Week 0 and 12 |
| Completion of Self-monitoring of Dietary Intake and Physical Activity | The 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. | Week 0 and 12 |
| Change in Weight Loss Self-efficacy | Self-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. | Week 0 and 12 |
| Autonomous and Controlled Motivation | At 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. | Week 12 |
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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.
| COMPLETED |
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| NOT COMPLETED |
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Statistical analyses were performed using the Statistical Package for the Social Sciences (IBM-SPSS, version 21.0). Statistical significance was accepted at the p<0.05 level of confidence. Analyses were conducted using individuals who completed assessments at week 0 and 12, with intent-to-treat (ITT) analysis carrying the baseline data forward.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Behavioral Weight Loss Intervention (SBWL) | Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period. | Posted | Mean | Standard Deviation | kg | Week 0 and 12 |
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| Secondary | Change in Physical Activity | A questionnaire will be used to measure and quantify energy expenditure from physical activity. | Posted | Mean | Standard Deviation | kcals/wk | Week 0 and 12 |
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| Secondary | Change in Dietary Intake: Kcals/Day | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Posted | Mean | Standard Deviation | kcals/day | Week 0 and 12 |
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| Secondary | Change in Dietary Intake: % Fat | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Posted | Mean | Standard Deviation | percentage of fat intake | Week 0 and 12 |
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| Secondary | Change in Dietary Intake: % Protein | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Posted | Mean | Standard Deviation | percentage of protein intake | Week 0 and 12 |
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| Secondary | Change in Dietary Intake: % Carbohydrate | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. | Posted | Mean | Standard Deviation | percentage of carbohydrate intake | Week 0 and 12 |
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| Secondary | Completion of Self-monitoring of Dietary Intake and Physical Activity | The 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. | Posted | Mean | Standard Deviation | percentage of diaries completed | Week 0 and 12 | Eating and Exercise Diary | Participants |
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| Secondary | Change in Weight Loss Self-efficacy | Self-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. | Posted | Mean | Standard Deviation | units on a scale | Week 0 and 12 |
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| Secondary | Autonomous and Controlled Motivation | At 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. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Behavioral Weight Loss Intervention (SBWL) | Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. | 0 | 13 | 0 | 13 | ||
| EG001 | 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. | 0 | 13 | 0 | 13 |
Not provided
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Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David O. Garcia, PhD | University of Arizona | 520-626-4641 | davidogarcia@email.arizona.edu |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| >=65 years |
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| Male |
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| Eating and Exercise Diary |
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| Units |
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| Counts |
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