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Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01803737
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
5.9
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)
  • Behavioral: Campaign Intervention (CI)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Behavioral Weight Loss Intervention (SBWL)

Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.

Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Experimental: Campaign 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.

Behavioral: Campaign 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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Change in Physical Activity [Week 0 and 12]

    A questionnaire will be used to measure and quantify energy expenditure from physical activity.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Physical Activity and Weight Management Research Center Pittsburgh Pennsylvania United States 15217

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: David O Garcia, MS, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
David Garcia, Doctoral Student, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01803737
Other Study ID Numbers:
  • PRO12110211
First Posted:
Mar 4, 2013
Last Update Posted:
Feb 17, 2014
Last Verified:
Jan 1, 2014
Keywords provided by David Garcia, Doctoral Student, University of Pittsburgh
Weight Loss
Physical Activity
Dietary Intake
Weight Loss Self-Efficacy
Motivation
Additional relevant MeSH terms:
Body Weight
Overweight
Weight Loss

Study Results

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.
Pre-assignment Detail
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Period Title: Overall Study
STARTED 13 13
COMPLETED 12 10
NOT COMPLETED 1 3

Baseline Characteristics

Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI) Total
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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 of all reporting groups
Overall Participants 13 13 26
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
13
100%
13
100%
26
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
42.5
(9.1)
43.8
(9.0)
43.1
(8.9)
Sex: Female, Male (Count of Participants)
Female
11
84.6%
11
84.6%
22
84.6%
Male
2
15.4%
2
15.4%
4
15.4%
Region of Enrollment (participants) [Number]
United States
13
100%
13
100%
26
100%

Outcome Measures

1. Primary Outcome
Title Change in Body Weight
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [kg]
-5.6
(2.9)
-3.1
(3.4)
2. Secondary Outcome
Title Change in Physical Activity
Description A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Time Frame Week 0 and 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [kcals/wk]
983.3
(567.6)
776.3
(1194.8)
3. Secondary Outcome
Title Change in Dietary Intake: Kcals/Day
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [kcals/day]
474.8
(509)
242.5
(709.3)
4. Secondary Outcome
Title Change in Dietary Intake: % Fat
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [percentage of fat intake]
-3.26
(5.58)
-0.00
(4.27)
5. Secondary Outcome
Title Change in Dietary Intake: % Protein
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [percentage of protein intake]
0.73
(2.38)
0.44
(2.57)
6. Secondary Outcome
Title Change in Dietary Intake: % Carbohydrate
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [percentage of carbohydrate intake]
0.64
(6.15)
0.90
(5.24)
7. Secondary Outcome
Title Completion of Self-monitoring of Dietary Intake and Physical Activity
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Measure Eating and Exercise Diary 143 143
Mean (Standard Deviation) [percentage of diaries completed]
91.6
(18)
60.1
(38.5)
8. Secondary Outcome
Title Change in Weight Loss Self-efficacy
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 13 13
Mean (Standard Deviation) [units on a scale]
28.3
(35.7)
16.3
(35.8)
9. Secondary Outcome
Title Autonomous and Controlled Motivation
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Measure Participants 12 10
Autonomous Motivation
6.3
(0.9)
5.3
(1.5)
Controlled Motivation
2.9
(1.1)
2.9
(1.0)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
All Cause Mortality
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/13 (0%) 0/13 (0%)
Other (Not Including Serious) Adverse Events
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/13 (0%) 0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title David O. Garcia, PhD
Organization University of Arizona
Phone 520-626-4641
Email davidogarcia@email.arizona.edu
Responsible Party:
David Garcia, Doctoral Student, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01803737
Other Study ID Numbers:
  • PRO12110211
First Posted:
Mar 4, 2013
Last Update Posted:
Feb 17, 2014
Last Verified:
Jan 1, 2014