Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Weight Loss Clinical Trial

Official title:

Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585193
• Other study ID #: PRO15040047
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: August 22, 2017
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While some evidence on weight change elicited from commercially available weight loss programs, such as Weight Watchers, is available, there is little evidence evaluating any health-related outcomes that result from losing weight through these programs. In addition, little data exists on the adherence and satisfaction of these types of programs. The purpose of this study is to evaluate body weight and health-related outcomes that are achieved from participating in a Weight Watchers program, along with program adherence and satisfaction. Men and women (N=150) that are participating in Weight Watchers weight loss program will undergo assessments at the University of Pittsburgh to evaluate outcomes related to the Weight Watchers 6 month intervention. Assessment visits, separate from the intervention, will take place at baseline (0 months), 3 months and 6 months for approximately 90 minutes at the Physical Activity and Weight Management Research Center. Participants will be asked to undergo assessments of body weight, height, aerobic stamina, functional fitness, flexibility, and complete a series of questionnaires related to demographics, program satisfaction, sleep quality, happiness, and food cravings. Adherence to the program will be measured by the number of group sessions attended.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Physical Activity and Weight Management Research Center / University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Change	To examine the effect of a 24-week commercially available weight loss program on weight change.	6 months
Secondary	Change in Sleep Quality and Duration	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
Secondary	Change in Happiness	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
Secondary	Change in Food Cravings	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
Secondary	Program Satisfaction	Program Satisfaction. Two parts to evaluate: Satisfaction Survey. Participants will be asked to complete a program Satisfaction Survey. The Satisfaction Survey is a self-administered survey scored on a 5-point Likert scale.; Open-ended Satisfaction Survey. Participants will be asked to complete a Open-ended Satisfaction survey that consist of 2 open-ended questions, and asked respondents to report on their satisfaction with the dietary plan.	6 months
Secondary	Program Adherence	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
Secondary	Change in Aerobic Capacity, Functional Fitness, Balance, Flexibility	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