Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the acceptability and efficacy of a modified Weight
      Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.
    

Detailed description: 
      The following assessment measures will be taken at 0, 3, and 6 months:

      Weight measurements. Weight will be taken according to the National Health and Nutrition
      Examination survey anthropometry procedures manual. Weight will be measured in kilograms to
      the nearest 0.1 kg using a calibrated digital scale (Tanita, Inc.) with participants in light
      clothing and no shoes. Two measurements will be taken. and if the measures differ by more
      than 0.2 kg, a third measure will be taken. An average of the closest two measures will be
      calculated and used for data entry.

      Waist circumference. Waist circumference will be assessed at baseline, 3 and 6 months. Waist
      circumference will be taken according to the National Health and Nutrition Examination survey
      anthropometry procedures manual. Measurements will be taken to the nearest 0.1cm, at the top
      of the pelvis ilium (just above the hip bone) with a non-stretchable tape measure, without
      compressing the skin, at the end of normal expiration. Two measurements will be taken with a
      third if the first two do not fall within 0.5 cm.

      Aerobic stamina. Aerobic stamina will be assessed using the 6 minute walk test. Distance
      traveled in meters (m) is the outcome.

      Flexibility. Flexibility will be assessed with the Classic Sit and Reach Test and reported in
      inches less than or greater than reached on a 20 inch reference mark as measured on a yard
      stick placed between the legs.

      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).

      Happiness. The Oxford Happiness Questionnaire will be used to assess happiness at 0, 3, and 6
      months. 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).

      Sleep. Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) to
      assess sleep quality and duration at 0, 3, 6. The PSQI is a validated self-report measure of
      sleep duration and sleep quality. The PSQI examines seven components of sleep quality
      retrospectively over a period of four weeks: subjective sleep quality, sleep latency, sleep
      duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and
      daytime dysfunction over the last month. The patient self-rates each of these seven areas of
      sleep. Scoring of answers is based on a 0-3 scale, whereby '3' reflects the negative extreme
      on the Likert scale. The global score is generated by summing up all seven component scores
      and ranges from 0 to 21, with higher values corresponding to reduced sleep quality.

      Weight related quality of life. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is
      a validated self-report measure for an individual's perception of how their weight affects
      their day-to-day life. Respondents rate the degree to which their weight affects them on 31
      items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4,
      usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function,
      self-esteem, sexual life, public distress, and work).

      Perceived Hunger. The Visual Analogue Scale (VAS) measures sensations that range across a
      continuum of values and cannot be easily directly measured. Operationally, the VAS is a
      horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., Not
      at all hungry, Extremely hungry) at each end. Participants will be asked to complete a three
      item VAS by placing a mark on the line at the point they feel represents their response to
      the question.

      Program Satisfaction. The Satisfaction Survey is a self-administered survey with 25 items
      scored on a 5-point Likert scale. This measure will be completed at only at 6 months.
    

Intervention name(s): Modified Weight Watchers plan
Intervention type(s): Behavioral
Intervention description(s): Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment