- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01742572
New DIETs: New Dietary Interventions Enhancing the Treatment for Weight Loss (New DIETs)
NEW Dietary Interventions to Enhance the Treatments for Weight Loss (NEW DIETs for Weight Loss Study)
Panoramica dello studio
Descrizione dettagliata
This study involves five groups. Participants will be randomly assigned to one of these groups. All groups will receive information on a dietary approach aimed at losing weight. All groups will be asked to favor foods that are low fat and have a low glycemic index, which means they will be asked to favor foods that don't cause a quick rise in blood sugar (for example, choosing oatmeal over cornflakes for breakfast). All groups will also be asked to take a vitamin B-12 supplement each day of their choosing (can be a multivitamin).
Participants who are eligible on the online screener will be contacted by phone to complete a few additional screening questions and invited to an orientation meeting.
Below are the steps in the study:
- If participants are accepted into the study, participants will come to the study site (USC Public Health Research Center) to learn more about the study, have their weight and height measured, learn how to complete questionnaires online, and complete their consent form. This meeting will last approximately 1.5 hours.
- Participants will then complete some questionnaires that measure their diet and physical activity levels on a computer at home or other location where participants have computer/internet access. We will also ask participants to keep all their grocery and restaurant receipts during this time to bring back with participants to the next meeting.
- Participants will come back for a meeting to have their weight measured again and participants will find out their diet group assignment. Participants will receive a 1.25 hour overview of the diet participants have been assigned to and be provided with materials on this diet.
If participants are assigned to the vegan, vegetarians, pesco-, or semi-vegetarian diets, they will complete the following over the 8-week study:
- Participants will attend weekly meetings over 8 weeks.
- We will obtain their weight and collect online questionnaires at weeks 4 and 8.
- During the 8-week study, we will ask participants to complete an online weekly questionnaire which will assess if participants are following the diet and their weight. This will take approximately 5 minutes to complete.
If participants are assigned to the omnivorous diet, they will only come in for meetings at baseline, 4 weeks, and 8 weeks.
- We will obtain their weight and collect online questionnaires at weeks 4 and 8.
- Participants will receive e-mailed lessons of their diet plan each week.
- During the 8-week study, we will ask participants to complete an online weekly questionnaire which will assess if participants are following the diet, and their weight. This will take approximately 5 minutes to complete.
- At week 8, participants will also be provided with information about the other 4 diets in case participants would like to try these dietary patterns after the study.
- All diet groups will be asked to collect and turn in all grocery store and restaurant receipts for 2 weeks prior to the start of the intervention and for the 8 weeks during the study.
- At study completion (8 weeks), participants will receive an incentive for participating ($20).
- Participants in all groups will be asked to take a daily multivitamin (or other reliable source of vitamin B-12) over the course of the study. You are responsible for choosing and purchasing this.
- During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
South Carolina
-
Columbia, South Carolina, Stati Uniti, 29208
- University of South Carolina
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- be between the ages of 18-65
- have access to a computer with Internet capabilities
- be overweight (Body Mass Index of 25-49.9)
- be able to attend weekly evening meetings at the University of South Carolina in Columbia, SC (up to 8 total) starting late January 2013.
Exclusion Criteria: Participants will be ineligible to participate if they:
- have a Body Mass Index less than 25 or greater than 49.9 kg/m2
- are currently pregnant
- are younger than 18 or older than 65 years of age
- are unable to attend weekly meetings for 8 weeks
- don't have access to the Internet and a computer
- don't have access to a scale for self-monitoring weight
- aren't willing to be randomized to one of five dietary groups
- have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
- have an eating disorder (participants will be screened using the Eating Attitudes Test screener-participants who do not pass this screener will be asked to contact their physician)
- currently participating in a weight loss program or taking weight loss medications
- currently following a vegan, vegetarian, or pesco-vegetarian diet
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Vegan
A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans.
We will also ask you to keep foods low in fat and low in glycemic index.
|
Change in dietary intake
|
|
Sperimentale: Vegetarian
A vegetarian diet is one that does not contain meat, fish, or poultry but does contain eggs and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans.
We will also ask you to keep foods low in fat and low in glycemic index.
|
Change in dietary intake
|
|
Sperimentale: Pesco-Vegetarian
A pesco-vegetarian diet is one that does not contain meat or poultry but does contain fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans.
We will also ask you to keep foods low in fat and low in glycemic index.
|
Change in dietary intake
|
|
Sperimentale: Semi-Vegetarian
A semi-vegetarian diet is one that contains all foods, including meat, poultry, fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans.
However, red meat is limited to one time per week and poultry is limited to 5 times per week or less.
We will also ask you to keep foods low in fat and low in glycemic index.
|
Change in dietary intake
|
|
Comparatore attivo: Omnivorous
An omnivorous diet contains all food groups.
However, as part of this study, we will ask participants in this group to keep foods low in fat and low in glycemic index.
Participants in this group will not need to attend weekly meetings but will receive information via e-mail each week.
|
Change in dietary intake
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Weight Loss
Lasso di tempo: 8 weeks
|
8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dietary Intake
Lasso di tempo: 8 weeks
|
Changes in dietary intake will be measured using 2 days of 24-hour dietary recalls
|
8 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Brie Turner-McGrievy, PhD, MS, RD, University of South Carolina
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00021116
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Diet
-
Vastra Gotaland RegionGöteborg UniversityIscrizione su invito
-
Mondelēz International, Inc.KGK Science Inc.Completato
-
Wake Forest University Health SciencesmBIOTANon ancora reclutamentoLa sperimentazione dell'editto - terapia per i razzi infiammatori della malattia intestinale (EDICT)Malattia infiammatoria intestinaleStati Uniti
-
University of GlasgowCompletatoMorbo di Crohn | Modifica dieteticaRegno Unito
-
University of HawaiiNational Cancer Institute (NCI); National Institutes of Health (NIH); University...Sospeso
-
Hospital de Clinicas de Porto AlegreTerminatoPressione sanguignaBrasile
-
Wolfson Medical CenterTerminatoColite ulcerosaIsraele, Francia, Italia
-
Maxima Medical CenterReclutamentoCandidato alla chirurgia bariatrica | Dieta chetogenicaOlanda
-
Quadram Institute BioscienceUniversity of East Anglia; The Coca-Cola CompanyCompletato