- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02585193
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15261
- Physical Activity and Weight Management Research Center / University of Pittsburgh
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Muut: 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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Body Weight Change
Aikaikkuna: 6 months
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To examine the effect of a 24-week commercially available weight loss program on weight change.
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6 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in Sleep Quality and Duration
Aikaikkuna: 6 months
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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.
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6 months
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Change in Happiness
Aikaikkuna: 6 months
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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).
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6 months
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Change in Food Cravings
Aikaikkuna: 6 months
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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).
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6 months
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Program Satisfaction
Aikaikkuna: 6 months
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Program Satisfaction. Two parts to evaluate:
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6 months
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Program Adherence
Aikaikkuna: 6 months
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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.
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6 months
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Change in Aerobic Capacity, Functional Fitness, Balance, Flexibility
Aikaikkuna: 6 months
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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
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Renee J Rogers, PhD, University of Pittsburgh
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- PRO15040047
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