NCT01803737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 17, 2014

Completed
Last Updated

February 17, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

February 28, 2013

Results QC Date

November 4, 2013

Last Update Submit

January 3, 2014

Conditions

Weight Loss

Keywords

Weight LossPhysical ActivityDietary IntakeWeight Loss Self-EfficacyMotivation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Change in Physical Activity

    Week 0 and 12

  • Change in Dietary Intake: Kcals/Day

    Week 0 and 12

  • Change in Dietary Intake: % Fat

    Week 0 and 12

  • Change in Dietary Intake: % Protein

    Week 0 and 12

  • Change in Dietary Intake: % Carbohydrate

    Week 0 and 12

  • +3 more secondary outcomes

Study Arms (2)

Standard Behavioral Weight Loss Intervention (SBWL)

ACTIVE COMPARATOR

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

Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)

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.

Behavioral: Campaign Intervention (CI)

Interventions

Standard Behavioral Weight Loss Intervention (SBWL)BEHAVIORAL

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

Standard Behavioral Weight Loss Intervention (SBWL)
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.

Campaign Intervention (CI)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Body mass index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m²
  • Ability to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Physical Activity and Weight Management Research Center

Pittsburgh, Pennsylvania, 15217, United States

Location

Related Publications (114)

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MeSH Terms

Conditions

Weight LossMotor Activity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
David O. Garcia, PhD
Organization
University of Arizona
davidogarcia@email.arizona.edu
520-626-4641

Study Officials

  • David O Garcia, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 17, 2014

Results First Posted

February 17, 2014

Record last verified: 2014-01

Locations

US(1)