Prepackaged Foods to Promote Weight Loss

The first study aim is (1) to test, in a randomized controlled trial, whether provision of
portion-controlled prepackaged lunch and dinner entrees in the context of a reduced-energy
diet prescription and counseling is associated with a greater degree of weight loss at 12
weeks in overweight or obese men and women, compared to usual care or control conditions in
which the prescribed reduced-energy diet is to be consumed via self-selected foods. This
study utilizes a randomized study design with participants assigned to the prepackaged food
intervention arms or a usual care control group. The second study aim is (2) to describe the
effect of participation in the prepackaged food arms (versus control conditions) on
circulating lipids (fasting total plasma cholesterol and triglycerides, low-density
lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol), carotenoids
(a biomarker of vegetable and fruit intake), C-reactive protein, and cardiopulmonary
fitness.

Secondary aims of this study are (3) to describe the association between prepackaged food
consumption on meal satiety, eating attitudes and behavior, and meal satisfaction. The
hypothesis to be tested is that eating a reduced-energy diet that incorporates unit-defined,
prepackaged foods is associated with meal satiety and satisfaction that is superior to a
diet based on self-selected foods.

As an exploratory aim, we also will examine whether there is a differential response to
different dietary macronutrient composition in the prepackaged food items used in the
structured meal plan in intervention participants. Lean Cuisine meal products will be
offered to participants assigned to one intervention group, and only Lean Cuisine items with
protein contributing >25% energy will be offered to participants in the other intervention
group.

Notably, the results of this study may contribute valuable data to the scientific knowledge
base regarding the various aspects of diet and diet composition that may promote more
successful weight loss. How diet can be best modified to promote weight loss is an important
issue currently being considered and debated among clinical and community-based behavioral
and nutritional scientists, and the optimal composition for weight loss diets has not been
established (IOM 2002). Adherence to any dietary regimen and energy imbalance is a central
determinant of successful weight loss, and evidence-based approaches that may promote better
adherence with less deprivation and more meal satisfaction could help public health and
clinical efforts to reduce the high prevalence of overweight and obesity in the U.S. today.

Inclusion Criteria:

- overweight or obese men and women

- Aged 25-65 years

- initial BMI >27.0 kg/m2 and < 40 kg/m2

- no eating disorders, food allergies or intolerances

- no history of bariatric surgery

- willing and able to participate in clinic visits and study interactions at specified
intervals

- maintain contact with the investigators for at least three months

- willing to allow blood collections

- capable of performing a simple test for assessing cardiopulmonary fitness

Exclusion Criteria:

- inability to participate in physical activity because of co-morbidity or disability
(e.g., severe arthritic conditions);

- a history or presence of a comorbid disease for which diet modification and increased
physical activity may be contraindicated or complicated;

- self-reported pregnancy or breastfeeding or planning a pregnancy within the next two
years;

- currently actively involved in another diet intervention study or organized weight
loss program;

- a history or presence of a significant psychiatric disorder or any other condition
that, in the investigator's judgment, would interfere with participation in the
trial.