- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02585193
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially available weight loss program, on changes in body weight. The current investigation aims to add to this body of evidence by providing additional data on changes in body weight and enhance the current evidence-base in regards to evaluating other health-related outcomes.
There is no evidence that demonstrates whether or not the weight loss as a result of the Weight Watchers program elicits changes in health-related outcomes related to aerobic capacity, flexibility, functional fitness, sleep, and other psychological measures. Additionally, within a scientific research protocol, measures of adherence and satisfaction have not been evaluated. This study will evaluate these outcomes beyond weight changes achieved across the 24-week program.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Spojené státy, 15261
- Physical Activity and Weight Management Research Center / University of Pittsburgh
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Male or female over age 18. Set "soft quotas" on the number of male and female participants - The desire is to have a 90% female / 10% male split.
- With or without previous Weight Watchers experience. Set quota on the number of participants with previous Weight Watchers experience at 65%.
- Self reported height/weight resulting in a Body Mass Index (BMI) of 27 to 43 kg/m2 (will re-screen at facility).
- Self report that he/she feels the need to lose weight.
- Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement.
- Willing to follow recommendations required by study protocol.
- Willing to include demographic information (e.g., ethnicity, income and education).
- Willing to participate in consumer surveys and focus groups as a part of the intervention.
- Use of a personal smartphone on a daily basis. For Android devices, must be version 4.4 (code: KitKat) or 5.0 (codename: Lollipop). For iPhones, must be iOS6 and above. Cannot accommodate Blackberry devices.
- The willingness and ability to navigate and use applications on their smartphone on a daily basis (minimum training will be provided).
- Reliable home WiFi access
Ability to commit to attending up to 27 study visits in approximately 26 weeks:
- Ability to commit (to best of their ability) to attending weekly meetings, 30-60 minutes in duration, at the same day and time each week for 24 consecutive weeks (daytime and evening options will be available).
- Ability to commit to up to 3 additional study visits at Weeks 0, 12, and 24, each approximately 90 minutes in duration, to complete assessments (height, weight, questionnaires, physical measures).
Exclusion Criteria:
- Participants that are currently following a commercial weight-loss program.
- Participants that have been involved in a related market research program within the last 6 months.
- Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
- Recent weight loss of ≥ 5 kg in the previous 3 months.
- History of clinically diagnosed eating disorder.
- Orthopedic limitations preventing participation in regular physical activity.
- Untreated thyroid disease or > 1 change in dose or type of thyroid medication over previous 6 months.
Taking any prescription medication with known effects on appetite or weight.
*With the exception of subjects on a stable dose of SSRIs (Selective Serotonin Re-uptake Inhibitors) for 6 months.
- Taking oral steroids.
- Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable).
- Previous surgical procedure for weight loss.
- Major surgery within the previous 3 months.
- History of heart problems (e.g., angina, bypass surgery, MI, etc) within previous 3 months.
- Presence of implanted cardiac defibrillator or pacemaker.
- Uncontrolled hypertension self-reported BP > 160/100mmHg)
- Diuretic use for hypertension over 1.5mg per day
- Diagnosis of type 1 or type 2 diabetes
- History of presence of cancer (completely respected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
- Consuming more than 14 alcoholic drinks per week or not more than 3 drinks per day.
- Planning to relocate in the next 9 months
- Any orthopedic limitation preventing participation in regular physical activity.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Weight Watchers Intervention
All participants are enrolled in this single arm of the study.
All participants receive the Weight Watchers intervention which consists of weekly group intervention/support meetings in which weight loss behaviors (diet, physical activity) are discussed.
|
All participants are enrolled in this single arm of the study.
All participants receive the Weight Watchers intervention which consists of weekly group intervention/support meetings in which weight loss behaviors (diet, physical activity) are discussed.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body Weight Change
Časové okno: 6 months
|
To examine the effect of a 24-week commercially available weight loss program on weight change.
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Sleep Quality and Duration
Časové okno: 6 months
|
Sleep quality and duration.
Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) at baseline, Months 3 and 6.
The PSQI is a validated self-report measure of sleep duration and sleep quality.
|
6 months
|
|
Change in Happiness
Časové okno: 6 months
|
Participants will be asked to complete the Oxford Happiness Questionnaire at baseline, Months 3 and 6.
The OHQ is a validated self-report measure for broad personal happiness.
Respondents rate 29 sentences on a 6 point Likert scale (1, strongly disagree; 6, strong agree).
|
6 months
|
|
Change in Food Cravings
Časové okno: 6 months
|
The Food Craving Inventory-II (FCI-II) is a validated self-report measure for general cravings and cravings for specific types of foods and will be completed at baseline, Months 3 and 6.
Respondents rate the frequency of cravings since the last time they completed the survey for each of 33 food items using a five-point Likert scale (1, never; 2, rarely; 3, sometimes; 4, often; 5, always/almost every day).
The FCI-II consists of 5 scales (sweets, high fats, carbohydrates/starches, fast food fats, and fruits & vegetables) that constitute the higher order construct of food cravings (the total score).
|
6 months
|
|
Program Satisfaction
Časové okno: 6 months
|
Program Satisfaction. Two parts to evaluate:
|
6 months
|
|
Program Adherence
Časové okno: 6 months
|
Data on adherence (attendance at meetings and use of the points system) will also be collected.
Attendance data will be recorded by Weight Watchers staff at every meeting.
These data will be confirmed by a member of the research staff that will be attending the weekly Weight Watchers meetings.
In addition, the weekly weights obtained at the intervention sessions will be provided to the investigators by the intervention staff to allow for examination of the trajectory of weight loss.
|
6 months
|
|
Change in Aerobic Capacity, Functional Fitness, Balance, Flexibility
Časové okno: 6 months
|
Aerobic Capacity: Participants will complete a 6 minute walk test on a designated walking course. The 6 minute walk test is a measure of functional and aerobic capacity. Participants will asked to walk at a brisk, yet comfortable pace for a total of 6 minutes. Functional Fitness and Balance: The Short Physical Performance Battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests to measure functional fitness. Flexibility: Lower body flexibility will be assessed through the sit and reach test. The sit and reach is a common test to measure lower back and lower body flexibility. This will be collected 3 times with the best of 3 scores utilized. |
6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Renee J Rogers, PhD, University of Pittsburgh
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PRO15040047
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Ztráta váhy
-
Faeth TherapeuticsUkončenoPokročilý pevný nádor | Mutace PIK3CA | PTEN Loss of Function MutationSpojené státy
Klinické studie na Weight Watchers Intervention
-
University of North Carolina, Chapel HillWeight Watchers InternationalDokončeno
-
University of PennsylvaniaWW International IncDokončeno
-
University of British ColumbiaDokončeno
-
University of North Carolina, Chapel HillWeight Watchers InternationalDokončenoObezita | Ztráta váhy | Úprava stravy | Změna hmotnosti, těloSpojené státy, Kanada, Spojené království
-
Medical University of South CarolinaWeight Watchers InternationalDokončeno
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalDokončeno
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brown... a další spolupracovníciNábor
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalDokončeno
-
University of California, San FranciscoStaženo
-
The Miriam HospitalDokončeno