Weight Loss
Conditions
Keywords
Weight Loss, Physical Activity, Dietary Intake, Weight Loss Self-Efficacy, Motivation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
BEHAVIORALCampaign Intervention (CI)
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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 18-55 years of age * Body mass index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m² * Ability to provide informed consent
Exclusion criteria
* Regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. * Participation in a previous physical activity or weight management research project in the previous 6 months. * Weight loss of ≥5% of current body weight in the previous 6 months. * For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months. * History of myocardial infarction, coronary bypass surgery, angioplasty, or other heart-related surgeries. * History of orthopedic or physical complications that would prevent participation in exercise. * Currently taking any prescription medication that may affect metabolism and/or body weight (e.g., synthroid). * Currently being treated for any condition that could affect body weight, such as coronary heart disease, diabetes mellitus, uncontrolled hypertension, cancer, depression, and anxiety. * Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months. * Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg. Subjects with controlled hypertension will be allowed to participate if they obtain a medical doctor's written consent to ensure that it is safe to participate in a weight loss intervention. * Currently do not have access to a computer and the Internet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Week 0 and 12 | Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Intake: Kcals/Day | Week 0 and 12 | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. |
| Change in Dietary Intake: % Fat | Week 0 and 12 | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. |
| Change in Dietary Intake: % Protein | Week 0 and 12 | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. |
| Change in Physical Activity | Week 0 and 12 | A questionnaire will be used to measure and quantify energy expenditure from physical activity. |
| Completion of Self-monitoring of Dietary Intake and Physical Activity | Week 0 and 12 | 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. |
| Change in Weight Loss Self-efficacy | Week 0 and 12 | 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. |
| Autonomous and Controlled Motivation | Week 12 | 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. |
| Change in Dietary Intake: % Carbohydrate | Week 0 and 12 | A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. | 13 |
| 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. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Time | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Medical Reason | 0 | 1 |
Baseline characteristics
| Characteristic | Campaign Intervention (CI) | Standard Behavioral Weight Loss Intervention (SBWL) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Continuous | 43.8 years STANDARD_DEVIATION 9 | 42.5 years STANDARD_DEVIATION 9.1 | 43.1 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Body Weight | -5.6 kg | Standard Deviation 2.9 |
| Campaign Intervention (CI) | Change in Body Weight | -3.1 kg | Standard Deviation 3.4 |
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.
Time frame: Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Autonomous and Controlled Motivation | Controlled Motivation | 2.9 units on a scale | Standard Deviation 1.1 |
| Standard Behavioral Weight Loss Intervention (SBWL) | Autonomous and Controlled Motivation | Autonomous Motivation | 6.3 units on a scale | Standard Deviation 0.9 |
| Campaign Intervention (CI) | Autonomous and Controlled Motivation | Autonomous Motivation | 5.3 units on a scale | Standard Deviation 1.5 |
| Campaign Intervention (CI) | Autonomous and Controlled Motivation | Controlled Motivation | 2.9 units on a scale | Standard Deviation 1 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Dietary Intake: % Carbohydrate | 0.64 percentage of carbohydrate intake | Standard Deviation 6.15 |
| Campaign Intervention (CI) | Change in Dietary Intake: % Carbohydrate | 0.90 percentage of carbohydrate intake | Standard Deviation 5.24 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Dietary Intake: % Fat | -3.26 percentage of fat intake | Standard Deviation 5.58 |
| Campaign Intervention (CI) | Change in Dietary Intake: % Fat | -0.00 percentage of fat intake | Standard Deviation 4.27 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Dietary Intake: Kcals/Day | 474.8 kcals/day | Standard Deviation 509 |
| Campaign Intervention (CI) | Change in Dietary Intake: Kcals/Day | 242.5 kcals/day | Standard Deviation 709.3 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Dietary Intake: % Protein | 0.73 percentage of protein intake | Standard Deviation 2.38 |
| Campaign Intervention (CI) | Change in Dietary Intake: % Protein | 0.44 percentage of protein intake | Standard Deviation 2.57 |
Secondary
Change in Physical Activity
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Physical Activity | 983.3 kcals/wk | Standard Deviation 567.6 |
| Campaign Intervention (CI) | Change in Physical Activity | 776.3 kcals/wk | Standard Deviation 1194.8 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Change in Weight Loss Self-efficacy | 28.3 units on a scale | Standard Deviation 35.7 |
| Campaign Intervention (CI) | Change in Weight Loss Self-efficacy | 16.3 units on a scale | Standard Deviation 35.8 |
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.
Time frame: Week 0 and 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Behavioral Weight Loss Intervention (SBWL) | Completion of Self-monitoring of Dietary Intake and Physical Activity | 91.6 percentage of diaries completed | Standard Deviation 18 |
| Campaign Intervention (CI) | Completion of Self-monitoring of Dietary Intake and Physical Activity | 60.1 percentage of diaries completed | Standard Deviation 38.5 |