Evaluation of a Commercial Program on Weight Loss and Health Outcomes

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.

Inclusion Criteria:

- Body mass index (BMI) between 25 and 43 kg/m²

- Ability to read and speak English

- All ethnic groups will be recruited

- Self-report desire to lose weight and willing to follow study recommendations

- Use of an iPhone with iOS 8.0 or later for use on a daily basis, and basic app skills

- Have access to the internet via a computer, and basic computer skills

Exclusion Criteria:

- Currently following a commercial weight-loss program (including Weight Watchers) or
who followed a weight loss program in the previous 6 months or who were members of
Weight Watchers within the past 12 months

- Another member of the household participating in the study.

- Pregnant or nursing, or planning on becoming pregnant over the next 9 months.

- Planning to relocate in the next 9 months

- Involvement in another research study that would interfere with participation in this
study

- Excessive alcohol intake or dependence

- Recent weight loss of ≥ 5 kg in the previous 6 months.

- Report health problems that make weight loss or unsupervised exercise unsafe or
unreasonable (e.g., orthopedic limitations, heart problems, history or heart attack or
stroke)

- History of clinically diagnosed eating disorder.

- Untreated thyroid disease or and changes in dose or type of thyroid medication over
previous 6 months

- Chronic/inflammatory gastrointestinal disorders (Irritable Bowel Syndrome acceptable)

- Taking any prescription medication with known effects on appetite or weight

- Previous surgical procedure for weight loss.

- Major surgery within the previous 6 months.

- Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100
mmHg

- Diuretic use over 1.5mg per day

- Diagnosis of type 1 or type 2 diabetes

- Presence of implanted cardiac defibrillator or pacemaker.

- History of presence of cancer within past 5 years or current treatment for cancer
(completely resected basal or squamous cell carcinoma acceptable if treatment