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Eine Studie entspricht den Filterkriterien
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Lifestyle Intervention for Healthy Change (LIVE WELL)

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Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05956574 (LIVE WELL) ist eine interventionsstudie zur Untersuchung von Übergewicht und Adipositas und hat den Status offene rekrutierung. Die Studie startete am 1. April 2025 und soll 125 Teilnehmer aufnehmen. Durchgeführt von Augusta-Universität ist der Abschluss für 1. Mai 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. Februar 2025 aktualisiert.
Kurzbeschreibung
The purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. The investigators plan to recruit overweight/obese (BMI>25) males and females to participate. Participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. For a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). The investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. Following the six-month intervention, participants will complete a 3-month no contact phase. This no contact phase will provide insight into the effects of the study on weight loss maintenance. Our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.
Offizieller Titel

Healthy Living: Incorporating Lifestyle Interventions to Encourage a Reduction in Body Weight.

Erkrankungen
Übergewicht und Adipositas
Weitere Studien-IDs
  • LIVE WELL
  • 2020021-2
NCT-Nummer
Studienbeginn (tatsächlich)
2025-04
Zuletzt aktualisiert
2025-02-19
Studienende (vorauss.)
2027-05
Geplante Rekrutierung
125
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
physical activity
dietary intervention
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellNutrigenomix
Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.
Nutrigenomix, Personalized Dietary Plan
Personalized dietary plan.
Körperliche Aktivität
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Behavioral Counseling
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Aktives VergleichspräparatControl
Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.
Körperliche Aktivität
Participate in an exercise program to work up to 300 min/week of moderate-intensity activity.
Behavioral Counseling
Review behavioral counseling videos and participate in worksheets to assist with behavioral change.
Standard Dietary Plan
Receive a standard dietary plan
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Total body weight
Use of scale to measure total body weight
6-months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Age 18-40 years
  • BMI > 25 kg/m2
  • No cardiopulmonary disease
  • stable on medications for 3 months
  • weight stable (+/-5 pounds) for the past 3 months
  • Not pregnant or trying to get pregnant
  • Owns a smartphone
  • Able to walk unassisted
  • Not on supplemental oxygen

  • Under the age of 18 years
  • 40 years and older
  • Unable to participate in an exercise program
  • Currently pregnant
Verantwortliche Partei
Madison Kindred, Hauptprüfer, Assistant Professor, Augusta University
Zentrale Studienkontakte
Kontakt: Madison Kindred, PhD, 774-238-0591, [email protected]
1 Studienstandorte in 1 Ländern

Georgia

Augusta University, Augusta, Georgia, 30909, United States
Madison Kindred, PhD, Kontakt
Madison Kindred, PhD, Hauptprüfer
Offene Rekrutierung