- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02451800
Exercise: Improving Compliance and Long-term Weight Loss
12 oktober 2016 uppdaterad av: South Dakota State University
Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program.
Participants are randomized to one of three groups: in-class yoga, yoga by digital video disk (DVD), stretching by DVD.
Changes in weight loss and stress levels are monitored.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program.
The 6-month study includes a 3-month randomized, controlled trial using in-person yoga, a yoga DVD, and a stretching DVD (control group) followed by a 3-month post-intervention follow-up.
The study will be conducted to test the hypotheses that both in-person yoga classes and DVD yoga participation will result in 1) greater compliance with the Profile program, 2) greater weight loss during the yoga intervention, and 3) greater weight loss 3 months following completion of the intervention compared to the stretching intervention.
Compliance will be investigated using percent of days that dietary intake was entered online and percent of days that online records indicate that the program was followed.
Changes in weight will be measured using data transmitted from electronic scales that are provided as part of the Profile program.
In order to assess weight change after participation in the intervention we will ask participants to continue weighing themselves daily for 3 months following completion of the intervention regardless of whether they completed the Profile program or not.
Participants will complete online questionnaires on behavioral and appetite perceptions related to eating, food intake, stress levels, compliance with diet recommendations given to them by Sanford Profile, and perceived benefits of their intervention.
We will use these measures to determine the effect of yoga participation on eating behaviors and stress levels.
Studietyp
Interventionell
Inskrivning (Faktisk)
162
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
South Dakota
-
Brookings, South Dakota, Förenta staterna, 57006
- South Dakota State University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Must be participants in the Sanford Profile Program (weight loss program)
Exclusion Criteria:
- Must have physician approval if answers yes to Physical Activity Readiness Questionnaire (PARQ) questions
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: in-class yoga
The intervention is a in-class yoga course taught by yoga instructors for 3 times per week for 3 months.
This class is based on "Peggy Cappy's Program: More Yoga for Every Body".
Class is taught at Sanford Wellness Centers in Sioux Falls, South Dakota and Fargo, North Dakota.
Each class in 1 hour in length.
|
In-person yoga classes that meet for 3x/week for 3 months.
Each class is 1 hour.
|
Aktiv komparator: yoga by DVD
For the intervention participants are asked to do yoga at home following the "Peggy Cappy's Program: More Yoga for Every Body" DVD.
They are asked to complete these exercises 3 times per week for 3 months.
The DVD is 1 hour in length.
|
Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
|
Aktiv komparator: stretching by DVD
For the intervention participants are asked to do stretching exercises at home following "Bob Anderson's DVD-Stretching: the DVD".
They are asked to complete these exercises 3 times per week for 3 months.
The DVD is 1 hour in length.
|
Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight loss
Tidsram: 3 months
|
All participants are enrolled in a weight loss program.
This outcome will tell us whether yoga increases weight loss during the intervention.
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight loss
Tidsram: 6 months
|
This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.
|
6 months
|
Stress levels
Tidsram: 3 months
|
Stress levels are measured using the Perceived Stress Scale (PSS).
This outcome will tell us whether yoga participation reduces stress levels during intervention.
|
3 months
|
Stress levels
Tidsram: 6 months
|
Stress levels are measured using the Perceived Stress Scale (PSS).
This outcome will tell us whether yoga participation has a long-term (3 mo) effect on reducing stress after intervention stops.
|
6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Bonny L Specker, PhD, South Dakota State University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2015
Primärt slutförande (Faktisk)
1 juli 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
30 januari 2015
Först inskickad som uppfyllde QC-kriterierna
21 maj 2015
Första postat (Uppskatta)
22 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1411008
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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