- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02585193
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, 미국, 15261
- Physical Activity and Weight Management Research Center / University of Pittsburgh
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body Weight Change
기간: 6 months
|
To examine the effect of a 24-week commercially available weight loss program on weight change.
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Sleep Quality and Duration
기간: 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
기간: 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
기간: 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
기간: 6 months
|
Program Satisfaction. Two parts to evaluate:
|
6 months
|
|
Program Adherence
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Renee J Rogers, PhD, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Weight Watchers Intervention에 대한 임상 시험
-
University of North Carolina, Chapel HillWeight Watchers International완전한
-
Medical University of South CarolinaWeight Watchers International완전한
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers International완전한
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research...완전한
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로