Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
3. januar 2014 opdateret af: David Garcia, University of Pittsburgh
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
26
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15217
- University of Pittsburgh Physical Activity and Weight Management Research Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Standard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Body Weight
Tidsramme: Week 0 and 12
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Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.
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Week 0 and 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Physical Activity
Tidsramme: Week 0 and 12
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A questionnaire will be used to measure and quantify energy expenditure from physical activity.
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Week 0 and 12
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Change in Dietary Intake: Kcals/Day
Tidsramme: Week 0 and 12
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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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Week 0 and 12
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Change in Dietary Intake: % Fat
Tidsramme: Week 0 and 12
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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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Week 0 and 12
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Change in Dietary Intake: % Protein
Tidsramme: Week 0 and 12
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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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Week 0 and 12
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Change in Dietary Intake: % Carbohydrate
Tidsramme: Week 0 and 12
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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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Week 0 and 12
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Completion of Self-monitoring of Dietary Intake and Physical Activity
Tidsramme: Week 0 and 12
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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.
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Week 0 and 12
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Change in Weight Loss Self-efficacy
Tidsramme: Week 0 and 12
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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.
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Week 0 and 12
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Autonomous and Controlled Motivation
Tidsramme: Week 12
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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.
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Week 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David O Garcia, MS, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
1. juli 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
28. februar 2013
Først indsendt, der opfyldte QC-kriterier
1. marts 2013
Først opslået (Skøn)
4. marts 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO12110211
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